GE Healthcare Finland Oy: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S

Hazard

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

Details from the source

Reason for recall: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. Distribution: Worldwide - US Nationwide distribution. Quantity: 2857 Lot/code info: No UDI Manufacturing date range (YYYY-MM-DD date format, located underneath date of manufacture symbol): 2024-11-25 - 2025-05-31; 2025-07-07 Serial Nos. 021725-20339 021725-22682 120924-06125 120924-05011 120924-05830 120924-03583 120924-04467 120924-04447 031425-28687 120924-04436 120924-04240 021725-21549 021725-20604 5567418-SO-1-1 031425-30157 031425-28597 031425-29489 031425-28901 031425-28978 031425-28590 031425-29484 031425-29177 021725-21521 021725-20357 021725-20412 021725-22331 120924-04465 120924-07616 120924-07484 120924-07792 120924-07909 120924-07359 120924-07524 120924-06997 120924-07861 120924-08477 120924-07878 120924-07726 120924-07799 120924-08618 120924-07791 120924-08527 120924-07862 120924-08616 120924-08622 031425-29009 031425-28366 031425-30139 031425-28758 031425-29924 031425-29879 031425-28136 031425-29340 031425-29934 031425-28144 031425-28970 031425-29883 031425-28120 031425-27976 031425-29349 031425-28713 031425-28188 021725-22330 021725-21579 021725-21271 021725-20338 021725-20573 021725-21576 021725-22607 021725-20579 021725-22599 021725-21251 010625-13475 021725-22701 120924-05740 031425-28162 031425-29868 031425-28705 031425-29295 031425-29944 031425-29899 022625-25420 022625-26187 022625-25158 022625-26232 022625-26208 022625-26814 022625-26256 022625-26220 022625-26867 022625-26890 031425-28985 031425-30149 120924-04966 120924-04244 120924-06139 120924-08030 120924-05493 120924-07728 120924-05393 120924-04387 120924-05428 120924-06013 120924

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.