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

Philips North America Llc: Cardiac Workstation 7000. Product Number: 860441.

Medical DevicesSource: FDA (device) · Date: 2026-08-26

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 Llc
Product
Cardiac Workstation 7000. Product Number: 860441.
Reason / hazard
Device will intermittently provide inaccurate data related to native heart rate.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.
Recall initiated
2026-07-01
Code info
Product Number: 860441. UDI: (01)00884838094833. Serial Numbers: US22520232, US32520244, US32520248, US42520323, US42520320, US42520300, US52520333, US52520332, US52520345, US52520382, US52520359, US52520390, US52520373, US52520412, US52520420, US52520426, US52520461, US62520469, US62520470, US62520474, US62520476, US62520483, US72520504, US72520518, US72520531, US62520499, US72520500, US72520648, US72520526, US72520524, US72520522, US72520517, US72520590, US72520547, US72520592, US82520720, US72520603, US72520640, US72520580, US72520666, US82520755, US82520752, US82520762, US72520662, US72520652, US72520664, US82520771, US82520844, US82520782, US82520774, US82520769, US82520777, US82520775, US82520855, US82520820, US82520823, US82520824, US82520744, US72520678, US82520822, US82520821, US82520726, US72520667, US72520670, US72520668, US82520848, US72520669, US92520885, US82520857, US82520851, US82520863, US92520881, US92520890, US92520901, US92520903, US92520894, US92520905, US92520906, US92520981, USO2521043, USO2521042, USO2521050, USO2521128, USO2521092, USO2521122, USO2521065, USN2521141, US92520990, USN2521132, USN2521144, USN2521149, USN2521130, USN2521179, USN2521150, USN2521161, USN2521163, USN2521164, USN2521160, USO2521072, USN2521175, USN2521170, USN2521176, USN2521185, USN2521206, USN2521211, USN2521214, USN2521213, USN2521196, USN2521226, USN2521223, USN2521249, USN2521215, USN2521224, USN2521246, USN2521243, USN2521235, USN2521221, USN2521222, USN2521342, USN2521198, USN2521254, USN2521252, USN2521294, USN2521286, USN2521258, USN2521257, USN2521256, USN2521307, USN2521288, USN2521287, USD2521394, USN2521289, USN2521300, USN2521296, USD2521365, USN2521302, USD2521427, USD2521407, USD2521436, USD2521433, USD2521448, USD2521440, USD2521475, USD2521430, USN2521308, USD2521362, USD2521374, USN2521309, USD2521355, US12621548, US12621550, US12621553, US12621671, US12621672, US12621629, US12621713, US12621712, US12621711, US12621710, US22621762, US22621763, US22621777, US22621787, US22621796, US22621859, US32621881, US32621887, US32621893, US32621905, US32621886, US32621884, US32621894, US32621906, US32621907, US32621909, US32621910, USD2521420, USD2521409, USD2521411, USD2521416, USD2521422, US32621911, US32621918, US32621912, US32621913, US32621936, US32622017, US32621923, US32621980, US32621953, US32621952, US32621950, US32621954, US32621895, US32622011, US32622018, US32622051, US32622023, US32622077, US32622078, US32622046, US42622153, US32622027, US32622053, US32622052, US32622076, US32622064, US42622108, US32622065, US42622129, US42622123, US42622110, US42622148, US42622113, US42622111, US42622154, US42622147, US42622139, US42622146, US42622116, US42622149, US42622150, US42622222, US42622188, US42622183, US42622187, US42622156, US42622184, CN72420050, CN82420071, CNO2420085, CNN2420093, CNN2420096, CNN2420111, CNN2420115, CND2420119, CND2420145, CND2420134, CND2420150, CND2420151, CND2420168, CND2420167, CND2420169, CND2420171, CN12520174, CN22520206, CN22520215, CN22520218, CN22520214, CN22520226, CN22520242, CN32520246, CN42520274, CN42520317, CN42520291, CN52520389, CN52520379, CN52520445, CN52520460, CN52520454, CN62520466, CN62520487, CN72520565, CN72520650, CN72520631, CN82520721, CN72520651, CN82520758, CN82520764, CN82520791, CN82520792, CN82520793, CN82520837, CN82520842, CN82520864, CN82520809, CN92520880, CN92520871, CN92520923, CN92520929, CN92520970, CN92520935, CN92520979, CN92520976, CNO2521015, CNO2520997, CNO2521008, CNO2521007, CNO2521026, CNO2521030, CNO2520998, CNN2521156, CNN2521212, USN2521219, CNN2521230, CNN2521283, CNN2521260, USN2521291, CNN2521346, CNN2521345, CNN2521344, CNN2521343, CND2521375, CND2521352, CND2521415, CND2521439, USD2521429, CND2521506, CN12621557, CND2521535, CND2521544, CN12621562, CN12621580, CN12621577, CN12621576, CN12621579, CN12621690, CN12621687, CN12621696, CN12621697, CN12621698, CN22621734, CN22621799, CN22621798, CN32621877, CN22621874, CN32621875, CN32621888, CN32621890, CN32621896, CN32621968, CN32621997, CN32622002, CN32621990, CN32621983, CN32622007, CN32622008, CN32622005, CN32622006, CN32622021, CN32622047, CN32622066, CN32622075, CN42622107, CN42622124, CN42622134, CN42622220, CN42622221
Product quantity
1,810 units
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
99361
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