⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Philips North America: Patient Information Center iX; Software Version Number: 4.5.0

Medical DevicesSource: FDA (device) · Date: 2026-01-28

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips North America
Product
Patient Information Center iX; Software Version Number: 4.5.0
Reason / hazard
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.
Recall initiated
2025-12-22
Code info
Model Numbers: (1) 866389, (2) 866390; UDI-DI: (1) 00884838127074, (2) N/A; Serial Numbers: 4Z24-5CKL-P, 0P6C-4TL3-D, 6J58-3LL6-0, 216G-7PGV-E, 0F2U-1BLC-H, 291E-7HJU-A, 1M6W-1UP5-1, 4620-0XNW-5, 4W5R-3FHA-L, 6B73-3ZKP-K, 3E79-49M4-3, 4F6Y-70HU-P, 0128-2WG5-0, 0830-3RLW-W, 097K-7LPC-5, 0D2V-1BLC-8, 120T-17M9-A, 173C-20JM-J, 190B-64MU-U, 1K2J-15LB-P, 1L3T-7KGB-E, 2K06-4ZPR-X, 3916-5DJ6-Z, 3V7H-06MT-E, 412A-2WG5-Y, 4271-2NL7-M, 4Z3L-5PP3-0, 5D0E-3EH3-3, 5E0B-3EH3-D, 5E25-14LG-9, 657X-31N5-L, 6G5U-3FHA-R, 781T-7TJA-B, 7N3U-51MJ-B, 7P31-7NPM-P, 283X-7ZPB-A, 7H77-09GU-Z, 4C59-26K6-P, 4N0L-0FKE-2, 5Y0A-02P6-L, 494H-1CJJ-3, 326G-7PGV-A, 292G-3YNZ-9, 0V2A-6DHP-0, 6354-58M8-C, 4W5B-6JK9-A, 5M7K-0VKT-T, 3401-1FHE-M, 6R30-5BNT-N, 6N2E-7YK1-1, 6R0H-6AMX-T, 107C-62PF-Y, 2X1T-7TJA-H, 1M6G-7PGV-K, 1C4Z-6KKD-H, 0B3Z-2RHR-L, 7H39-3JGK-U, 0M0V-6FKB-5, 793D-41PZ-X, 233G-46MR-V, 782Z-3RLW-D, 5N2B-5YJP-G, 0L5F-0ZNF-J, 4G4N-2LKY-K, 2M48-4XM7-Y, 133W-3UN7-B, 295N-0YG8-Y, 5D7W-00G0-1, 5R78-6CPV-0, 3C79-49M4-9, 3T24-5CKL-A, 6H74-27LY-T, 186W-1UP5-8, 0021-1DNN-P, 0247-7ELE-R, 0D5Y-32PN-A, 0J7W-31N5-2, 0R2W-1VNP-P, 0Y5Z-7FHX-N, 121L-1KG1-M, 1366-7XLV-X, 144W-7RPJ-5, 1472-5WKF-X, 1C19-1MHK-F, 1G0F-69LP-G, 1J5U-5HMV-N, 1P4F-34MB-W, 1P5C-6JK9-D, 212R-6HHJ-P, 221V-7TJA-4, 227N-7JG6-J, 232W-7DL9-G, 2A5X-2PJT-0, 2A75-27LY-3, 2F5J-0JLM-7, 2J19-1MHK-W, 2L16-59N8-M, 2M73-5WKF-U, 2N3V-6YM2-X, 2P6J-7PGV-E, 2Y5M-5AGH-E, 326W-21KC-B, 332M-47P7-Y, 3A29-0CKW-3, 3C0U-7AHH-6, 3C2U-05HF-W, 3E05-4ZPR-U, 3G6H-39G4-Y, 3H1T-22HW-5, 3H5R-5HMV-M, 3H79-09GU-5, 3J2K-2TP9-1, 3W1Y-3CH6-J, 4L7Y-00G0-F, 4M77-1HM0-G, 4N3D-20JM-K, 4R0G-60JV-1, 4V2Z-7NPM-M, 4W08-0UH7-U, 4X6C-1PJ5-J, 4Y08-0UH7-L, 500W-6WNX-A, 594D-0EG2-9, 5U0A-3WPK-C, 5W1G-50P2-N, 5Z6J-3HL1-B, 617W-31N5-F, 637V-7BG9-W, 673T-67ME-B, 686N-3NNV-6, 6D3P-4WMG-A, 6K70-3XNY-W, 6P42-35J4-V, 6U1T-75JN-Y, 771A-2JPY-0, 7F5L-73HZ-3, 7G3A-13JG-L, 7K0P-4AH2-6, 7Z2R-05HF-X, 1J1P-6PKN-T, 4R7H-7LPC-J, 282N-0WPA-X, 5G35-04K8-E, 366L-2XHV-A, 5L7D-2UGW-T, 4N0L-0FKE-2;
Product quantity
146 units (41 US, 105 OUS)
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
98217
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