United StatesModels affected include CARESCAPE B450 (model 5805686), CARESCAPE ONE (model 2087075-300), B105P/B125P/B105M/B125M/B155M series patient monitors, Portrait VSM (model 6660000-666), and BATTERY FLEX‑3S2P 10.8V 18650 Li‑ion SMBUS batteries (model 2062895‑001, MPN U80296‑1R01, revision S). Affected units were shipped with or may contain these batteries as installed or spare parts and are identified by UDI‑DI 00840682146135 and the listed serial numbers. The recall was issued because the batteries can lose charge and back‑up capability, which can cause loss of patient monitoring and delay recognition of changes in patient status requiring treatment.
What's being recalled
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
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
Recalling firm: GE Healthcare Finland Oy, Helsinki, Finland.
How to identify it
UDI-DI 00840682146135 Serial numbers SNT25079613SA SNT25079608SA SNT25079622SA SNT25079618SA SNT25079619SA SNT25079614SA SNT25079611SA SNT25079621SA SNT25079620SA SNT25079603SA SNT25079616SA SNT25079612SA SNT25079602SA SNT25079615SA SNT25079663SA SNT25079664SA SNT25079677SA SNT25079662SA SNT25079667SA SNT25079678SA SNT25079680SA SNT25079666SA SNT25079695SA SNT25079694SA SNT25079697SA SNT25079688SA SNT25079687SA SNT25079685SA SNT25079676SA SNT25079674SA SNT25079671SA SNT25079691SA SNT25079689SA SNT25079679SA SNT25079681SA SNT25079684SA SNT25079672SA SNT25079668SA SNT25079665SA SNT25079675SA SNT25079693SA SNT25069004SA SNT25069001SA SNT25069002SA SNT25069003SA SNT25069013SA SNT25069007SA SNT25069015SA SNT25069012SA SNT25069014SA SNT25069016SA SNT25069017SA SNT25069021SA SNT25069019SA SNT25069006SA SNT25069020SA SNT25069005SA SNT25069008SA SNT25069009SA SNT25069018SA SNT25069023SA SNT25259594SA SNT25259577SA SNT25259590SA SNT25069508SA SNT25069564SA SNT25219502SA SNT25219501SA SNT25219504SA SNT25219503SA SNT25079536SA SNT25079537SA SNT25079558SA SNT25079532SA SNT25079569SA SNT25079539SA SNT25079526SA SNT25079571SA SNT25079575SA SNT25079576SA SNT25079572SA SNT25079574SA SNT25079533SA SNT25079524SA SNT25079573SA SNT24429994SA SNT25149512SA SNT25149514SA SNT25109580SA SNT25109578SA SNT25109576SA SNT25109579SA SNT25109577SA SNT25109574SA SNT25109575SA SNT25109581SA SNT25109573SA SNT25179587SA SNT25179583SA SNT25179577SA SNT25179573SA SNT25179574SA SNT25019477SA SNT24529475SA SNT24529472SA SNT25019494SA SNT25099727SA SNT25099728SA SNT25099729SA SNT25099730SA SNT25099732SA SNT25099733SA SNT25099736SA SNT25099735SA SNT25099737SA SNT25099738SA SNT25109521SA SNT25109514SA SNT25199525SA SNT25199527SA SNT25199528SA SNT25199519SA SNT25199521SA SNT25199526SA SNT25199524SA SNT25199540SA SNT25089012SA SNT25259570SA SNT25269581SA SNT25269583SA SNT25269582SA SNT25269589SA SNT25269591SA SNT25269588SA SNT25269594SA SNT25269599SA SNT25269596SA SNT25269593SA SNT25159685SA SNT24529627SA…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada