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Class IIOngoingZ-0457-2026

GE Healthcare Finland Oy recalls BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Mode…

GE Healthcare Finland OyHelsinki, FinlandReported Nov 19, 2025 · 8 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

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 #
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 031…Show all
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 120924-04841 120924-08550 120924-06003 120924-06135 120924-04210 021725-22415 031425-30066 031425-28908 031425-28289 031425-28010 031425-29583 031425-28980 031425-30088 031425-28467 031425-28402 031425-28164 031425-28699 031425-28036 031425-29029 031425-29593 031425-29205 031425-28994 031425-29211 031425-28425 031425-28051 031425-28130 031425-29646 031425-28424 031425-28446 031425-29630 031425-27842 031425-29012 031425-27815 031425-28055 031425-29897 031425-28768 031425-28749 031425-29054 031425-28157 031425-29359 031425-29139 031425-28760 031425-29316 031425-29925 031425-29875 031425-28723 031425-29962 031425-29328 031425-29904 031425-29298 031425-29957 031425-28165 031425-28716 031425-29932 031425-29156 031425-29753 031425-29905 031425-28170 031425-29354 031425-29233 031425-28692 031425-28138 031425-28770 031425-28693 021725-20387 021725-20415 021725-21314 021725-22700 021725-20584 120924-04199 120924-04922 031425-29613 031425-27829 120924-06022 031425-29461 031425-28006 031425-28581 031425-28589 031425-28986 031425-30165 031425-29582 031425-28899 031425-28898 031425-28582 031425-29550 031425-29173 031425-30154 031425-28902 031425-28337 031425-28910 031425-28022 031425-29894 031425-29908 031425-29249 031425-29284 031425-28134 031425-27816 031425-28135 031425-28696 031425-29014 031425-28436 031425-27817 031425-29202 031425-28600 031425-29614 031425-28394 031425-28585 031425-29350 010625-14241 010625-15358 010625-13996 010625-15453 010625-15073 010625-15218 010625-13945 010625-13863 010625-14254 010625-14512 120924-06097 120924-06115 120924-06205 120924-05369 120924-05975 120924-05910 120924-06106 120924-06085 120924-06082 120924-05886 120924-06211 120924-06356 120924-06239 120924-03923 120924-05624 120924-05371 120924-06105 120924-05924 120924-05634 120924-05380 020625-17686 020625-18546 031425-28556 020625-17694 020625-17717 031425-29387 020625-18154 031425-27979 031425-28268 031425-28776 031425-28533 031425-30170 031425-30003 031425-29758 031425-30051 031425-29371 031425-30053 031425-30054 031425-28843 031425-28518 031425-29377 031425-29149 010625-15192 010625-13994 021725-21266 021725-20414 021725-22385 021725-21272 021725-22719 021725-21320 021725-22327 021725-22399 021725-20333 021725-22602 021725-20366 021725-20411 021725-21575 021725-22391 021725-20400 021725-20587 021725-22596 021725-22336 021725-22635 021725-21516 021725-22665 021725-21318 021725-20395 021725-21519 021725-22677 021725-20643 021725-20636 021725-21631 021725-22402 021725-22606 021725-20381 021725-22590 021725-22644 021725-20564 021725-20647 021725-22376 021725-20640 021725-20574 010625-14199 010625-14396 021725-22628 021725-20659 010625-14964 021725-22655 010625-14188 021725-20596 021725-20379 031425-27889 031425-28367 031425-27859 031425-28377 031425-29565 031425-28568 031425-30081 031425-30121 031425-30116 031425-28476 031425-30174 120924-06095 120924-05236 120924-03978 120924-07724 120924-05039 120924-06027 120924-05819 120924-07970 120924-08134 120924-06408 010625-14587 120924-05635 120924-06246 120924-04508 120924-06243 120924-05920 120924-05930 120924-05937 120924-05884 120924-06236 120924-05018 120924-07883 120924-07381 120924-08632 120924-07220 120924-07871 120924-09366 120924-07874 120924-08897 120924-09065 120924-09070 022625-24297 022625-24717 022625-25309 022625-25855 022625-24698 022625-24770 022625-24732 022625-25460 022625-24295 022625-24120 022625-24105 022625-24326 022625-23980 022625-25610 022625-26870 022625-25806 022625-25386 022625-26304 022625-25969 022625-25613 022625-25344 031425-30184 022625-25974 022625-24161 022625-26691 022625-26811 022625-26017 022625-26005 031425-28748 031425-29936 031425-29872 031425-28751 031425-28734 120924-06960 120924-07510 112524-00773 112524-01458 112524-01116 112524-01090 112524-01077 112524-00999 112524-00996 112524-01646 112524-01403 112524-01659 112524-01594 112524-01581 120924-03825 112524-01336 120924-04409 112524-00923 112524-01380 112524-01093 112524-00775 112524-00770 112524-00780 120924-06744 120924-04430 112524-01494 120924-09083 120924-04408 120924-12546 120924-08927 120924-04414 120924-09549 120924-04424 120924-06970 120924-07445 120924-08535 031425-29477 021725-20706 021725-22383 021725-21242 021725-21245 021725-21339 021725-21267 021725-22638 021725-20615 120924-02677 120924-02969 120924-08696 120924-02317 120924-08358 120924-02918 120924-08376 120924-09357 120924-02624 120924-09021 120924-03893 022625-25122 022625-24281 022625-25146 022625-25106 120924-04003 120924-08065 120924-05500 120924-05992 120924-05660 120924-06407 120924-07994 120924-08068 120924-05376 120924-05655 120924-05816 120924-08083 120924-04450 120924-05808 12092 …
Additional code information

4 120924-04934 120924-03914 010625-14515 010625-15261 010625-15212 010625-14407 010625-13969 010625-14521 010625-15185 120924-06343 120924-06231 120924-06316 120924-06215 120924-06207 120924-05908 120924-05000 120924-06318 120924-06328 120924-06321 010625-13939 010625-15067 5564916-SO-2-1 031425-27878 031425-28406 031425-28041 120924-03631 120924-06113 120924-06347 120924-06132 120924-04449 120924-05531 120924-05283 120924-05907 120924-05509 120924-05545 031425-30125 120924-04224 120924-05498 031425-29882 031425-29862 021725-21524 021725-20591 021725-22641 021725-21581 021725-21316 021725-20651 021725-21586 021725-20569 021725-21531 021725-21609 021725-21607 021725-22642 021725-20394 021725-21315 021725-21529 120924-03584 120924-04943 120924-03827 120924-05261 120924-03619 120924-04953 120924-05322 120924-05321 120924-04898 120924-05314 031425-29788 031425-28624 031425-28189 021725-22620 021725-22623 031425-28697 031425-29191 031425-29209 021725-22388 021725-22690 021725-22400 021725-20619 120924-04900 010625-14536 010625-15177 120924-05899 031425-28470 021725-22636 031425-29596 031425-28185 120924-05768 120924-05813 120924-06260 120924-05052 120924-04783 120924-05834 120924-05996 120924-07982 120924-06326 031425-28684 031425-28285 031425-30069 031425-29800 021725-21539 041425-35140 120924-06116 120924-06109 120924-06336 120924-05919 120924-06118 021725-20409 031425-29672 5549343-SO-3-1 031425-30016 031425-28916 120924-03595 120924-05102 120924-03600 120924-05089 031425-29210 120924-06083 120924-05191 120924-05997 021725-22614 020625-17521 020625-17036 020625-17548 010625-12968 010625-13189 010625-13195 010625-13246 010625-13309 010625-13311 010625-13319 010625-13494 010625-13664 010625-13746 010625-13895 010625-14027 010625-14028 010625-14042 010625-14046 010625-14048 010625-14071 010625-14074 010625-14075 010625-14076 010625-14081 010625-14091 010625-14092 010625-14119 010625-14122 010625-14124 010625-14126 010625-14128 010625-14134 010625-14266 010625-14268 010625-14270 010625-14275 010625-14291 010625-14301 010625-14427 010625-14430 010625-14452 010625-14471 010625-14490 010625-14496 010625-14497 010625-14548 010625-14574 010625-14588 010625-14595 010625-14605 010625-14629 010625-14674 010625-14706 010625-14707 010625-14711 010625-14712 010625-14726 010625-14794 010625-14846 010625-14857 010625-15055 010625-15076 010625-15086 010625-15315 010625-15320 010625-15322 010625-15345 010625-15346 010625-15359 010625-15447 031425-28033 021725-21338 031425-28724 031425-28196 021725-22647 021725-22660 031425-29598 031425-28227 031425-28291 031425-29050 021725-22386 021725-20599 021725-22631 031425-28959 031425-29347 031425-29935 031425-29338 031425-28110 031425-29909 031425-29282 031425-29880 031425-29889 031425-29947 031425-29306 031425-29930 031425-28131 031425-28767 120924-05827 120924-05643 120924-05223 120924-06094 031425-29398 022625-24528 022625-26417 022625-26830 022625-26476 020625-17506 120924-05323 120924-05578 120924-06414 120924-05332 120924-05147 120924-05325 120924-09394 120924-05160 120924-05499 120924-09090 120924-09239 120924-06383 120924-09217 120924-06385 120924-09005 120924-06488 120924-06873 120924-08189 120924-06443 120924-05157 120924-04956 120924-05301 120924-05142 120924-04955 120924-05580 120924-06999 120924-05339 120924-08250 120924-08271 120924-08248 120924-06532 120924-07050 120924-08875 120924-06440 120924-06494 120924-06395 120924-09130 120924-06398 031425-28199 010625-13337 010625-14035 010625-13743 010625-14303 010625-13735 010625-14267 010625-14426 010625-13897 010625-13156 010625-14352 010625-14305 010625-14540 031425-29312 031425-29273 120924-03667 120924-06416 031425-29806 031425-29896 031425-29063 031425-30147 031425-28113 031425-28385 010625-14911 010625-15154 010625-15166 010625-13673 010625-15163 010625-14698 010625-14933 010625-15159 010625-14200 010625-14375 120924-05264 120924-08074 120924-04323 120924-07793 022625-26416 022625-26376 022625-26116 022625-26505 010625-14376 120924-06179 120924-04352 120924-03690 120924-03698 031425-29948 031425-29867 031425-28149 031425-28156 031425-29141 010625-14954 010625-14419 010625-15064 010625-13832 010625-15221 010625-15183 010625-15217 010625-14796 010625-15223 010625-14382 010625-13971 010625-13821 120924-06149 120924-07809 120924-05885 120924-06227 120924-06099 120924-05911 120924-06360 120924-04906 031425-29603 010625-14682 010625-14695 120924-05921 120924-06348 120924-06112 120924-06081 120924-06092 120924-06319 120924-03924 021725-20576 031425-28191 021725-21569 010625-15362 010625-15175 010625-15371 010625-14115 120924-05187 022625-24368 022625-25247 022625-24318 022625-26508 022625-26463 022625-24371 022625-25193 022625-26465 022625-26464 022625-25716 022625-24333 022625-26501 120924-06324 120924-05935 010625-15451 010625-14238 010625-13160 010625-15088 022625-24739 022625-24851 022625-24860 022625-23940 022625-26570 010625-15194

What the firm is doing

On September 26, 2025, the recalling firm began notifying affected customers. A second letter was issued on October 3, 2025 which addressed a correction to Affected Product Details information. The customer letter advised users to use a monitor with a battery that is not within the affected battery population. However, pending correction by GE HealthCare, users may continue to use a monitor with affected batteries by following instructions included in the letter. These instructions include having mains power connected whenever possible, confirming appropriate battery status prior to use, and being aware that the monitor may still shut down during patient transport. Users are advised to be prepared to provide alternate methods of assessing the clinical status of the patient, bring a mains power cord during patient transport, and bring a spare battery. GE HealthCare will correct all affected products at no cost to the customer. A GE HealthCare representative will contact each customer to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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