FDA Medical devices recall ·
B105P, B125P, B105M, B125M, B155M Patient Monitors recall
- Recall number
- Z-0455-2026
- Date
- (initiated September 26, 2025)
- Company / brand
- GE Healthcare Finland Oy
Kuortaneenkatu 2, Helsinki, Finland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7408
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 SR625060183SA SR625060184SA SR625060185SA SR625060186SA SR625060187SA SR625060188SA SR625060189SA SR625060190SA SR625170160SA SR625170161SA SR625170162SA SR625170163SA SR625170164SA SR625170165SA SR625170166SA SR625170167SA SR625170168SA SR625170169SA SR625170170SA SR625170156SA SR625070053SA SR625070054SA SR625070055SA SR625070056SA SR625070057SA SR625070058SA SR625070059SA SR625070060SA SR625070061SA SR625070062SA SR625070063SA SR625070064SA SR625070065SA SR625170146SA SR625170147SA SR625170148SA
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0455-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.