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Philips North America recalls - full list & free alerts

102 official U.S. recalls involving Philips North America in the last 12 months, most recently on 2026-10-07.

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Full list (102)

Philips North America Llc: Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S),
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6.
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Mod
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America: Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T
Medical DevicesFDA (device) · 2026-10-07 · Class II
Philips North America Llc: Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T),
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X),
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 7821
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America Llc: SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model N
Medical DevicesFDA (device) · 2026-09-30 · Class II
Philips North America: Philips Patient Information Center iX REF:866389
Medical DevicesFDA (device) · 2026-09-23 · Class II
Philips North America: Philips PIC iX Essentials REF:867093
Medical DevicesFDA (device) · 2026-09-23 · Class II
Philips North America Llc: Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305,
Medical DevicesFDA (device) · 2026-09-09 · Class II
Philips North America Llc: Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Medical DevicesFDA (device) · 2026-09-09 · Class II
Philips North America Llc: Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. S
Medical DevicesFDA (device) · 2026-09-09 · Class II
Philips North America Llc: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Medical DevicesFDA (device) · 2026-09-09 · Class II
Philips North America Llc: Cardiac Workstation 5000. Product Number: 860439.
Medical DevicesFDA (device) · 2026-08-26 · Class II
Philips North America Llc: Cardiac Workstation 7000. Product Number: 860441.
Medical DevicesFDA (device) · 2026-08-26 · Class II
Philips North America Llc: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Medical DevicesFDA (device) · 2026-07-01 · Class II
Philips North America Llc: Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Medical DevicesFDA (device) · 2026-07-01 · Class II
Philips North America Llc: Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG on
Medical DevicesFDA (device) · 2026-07-01 · Class II
Philips North America Llc: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Medical DevicesFDA (device) · 2026-06-17 · Class II
Philips North America: Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbe
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Nu
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Nu
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Num
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Num
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 78211
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America: Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Medical DevicesFDA (device) · 2026-05-06 · Class II
Philips North America Llc: Brilliance iCT; Product Code (REF): 728306;
Medical DevicesFDA (device) · 2026-02-18 · Class II
Philips North America Llc: IQon Spectral CT; Product Code (REF): 728332;
Medical DevicesFDA (device) · 2026-02-18 · Class II
Philips North America Llc: Spectral CT; Product Code (REF): 728333;
Medical DevicesFDA (device) · 2026-02-18 · Class II
Philips North America Llc: Spectral CT 7500 on Rails; Product Code (REF): 728334;
Medical DevicesFDA (device) · 2026-02-18 · Class II
Philips North America: Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Medical DevicesFDA (device) · 2026-02-04 · Class II
Philips North America: Patient Information Center iX; Software Version Number: 4.5.0
Medical DevicesFDA (device) · 2026-01-28 · Class II
Philips North America Llc: Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Medical DevicesFDA (device) · 2026-01-14 · Class II
Philips North America: Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Medical DevicesFDA (device) · 2025-12-17 · Class II
Philips North America Llc: IntelliVue MP2. Product Number: M8102A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP5. Product Number: M8105A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP20. Product Number: M8001A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP30. Product Number: M8002A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP40. Product Number: M8003A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP50. Product Number: M8004A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP60. Product Number: M8005A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP70. Product Number: M8007A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP80. Product Number: M8008A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue MP90. Product Number: M8010A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX100. Product Number: 867033.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX400. Product Number: 866060.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX450. Product Number: 866062.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX500. Product Number: 866064.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX550. Product Number: 866066.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX600. Product Number: 865242.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX700. Product Number: 865241.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX750. Product Number: 866471.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX800. Product Number: 865240.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: IntelliVue Patient Monitor MX850. Product Number: 866470.
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America Llc: CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Medical DevicesFDA (device) · 2025-12-10 · Class II
Philips North America: Cardiac Workstation 5000; Model Number: 860439;
Medical DevicesFDA (device) · 2025-10-22 · Class II
Philips North America: Cardiac Workstation 7000; Model Number: 860441;
Medical DevicesFDA (device) · 2025-10-22 · Class II