Cardiac Workstation 7000. Product Number: 860441.
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling 1,810 units of the Cardiac Workstation 7000 (Product Number 860441) distributed worldwide, including throughout the United States and numerous other countries. The device can intermittently provide inaccurate data related to native heart rate. The affected units are identified by specific serial numbers beginning with codes such as US22520232 through USN2521 and others listed in the recall notice.
The recall record does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Device will intermittently provide inaccurate data related to native heart rate.
Reason for recall: Device will intermittently provide inaccurate data related to native heart rate. 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, Swede Quantity: 1,810 units Lot/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, USN2521
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.