FDA Device recall Z-0455-2026
B105P, B125P, B105M, B125M, B155M Patient Monitors
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of B105P, B125P, B105M, B125M, B155M Patient Monitors 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-0455-2026 |
| 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
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
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 | Model No. 6160000-002 UDI-DI 00840682147224 Serial Nos. SR525270031WA SR525270032WA SR525270033WA SR525270034WA SR52527…Model No. 6160000-002 UDI-DI 00840682147224 Serial Nos. SR525270031WA SR525270032WA SR525270033WA SR525270034WA SR525270035WA SR525270036WA SR525270037WA SR525270038WA SR525270039WA SR525270040WA SR525270041WA SR525270042WA SR525270043WA SR525270044WA SR525270045WA SR525270046WA SR525270047WA SR525270048WA SR525270049WA SR525270050WA SR525270051WA SR525270052WA SR525270053WA SR525270054WA SR525270055WA SR525270056WA SR525270057WA SR525270058WA SR525270059WA SR525270060WA ; Model No. 6160000-003 UDI-DI 00840682146708 Serial Nos. SR625210256SA SR625200211SA SR625200212SA SR625200213SA SR625200214SA SR625200215SA SR625300322SA SR625170208SA SR625220268SA SR625130040SA SR625130041SA SR625130042SA SR625130043SA SR625130024SA SR625130025SA SR625130026SA SR625130027SA SR625130028SA SR625130029SA SR625130030SA SR625130031SA SR625130032SA SR625130033SA SR625130034SA SR625130035SA SR625170158SA SR625170159SA SR625240284SA SR625210265SA SR625210266SA SR625110137SA SR625060181SA SR625060182SA S |
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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-0455-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.