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TemporaryFDAOngoing

Can cause harm that is usually temporary.

Cardiac Workstation 7000. Product Number: 860441.

Check the device or its packaging for

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
Why
Device will intermittently provide inaccurate data related to native heart rate.
Distributed
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.
Company
Philips North America Llc
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Source: FDA record Z-2956-2026 · retrieved 14 August 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.

Local Recall