Cardiac Workstation 7000. Product Number: 860441 recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Cardiac Workstation 7000. Product Number: 860441.

Recalling firm

Philips North America Llc

Quantity

1,810 units

Distribution

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 date

August 26, 2026

Classification

Class II

Status

Ongoing

Agency

FDA (device)