FDA Device recall Z-0453-2026
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Ph…
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Ph… by Ge Healthcare Finland Oy, citing 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 situa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0453-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-26 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare Finland Oy |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | UDI-DI 00840682146135 Serial numbers SNT25079613SA SNT25079608SA SNT25079622SA SNT25079618SA SNT25079619SA SNT25079614…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 SNT2521950 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0453-2026%22
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