Class II U.S. Food and Drug Administration

GE Healthcare Finland Oy B105P, B125P, B105M, B125M, B155M Patient Monitors recall: Potential loss of monitoring on affected monitors when powered by certain

Recall published 11 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0455-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Healthcare Finland Oy
Product type
Medical devices
Units affected
7408
Distribution
Nationwide
Made in
Finland
Lot / code info
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 SR625170149SA SR625170150SA SR625170151SA SR625170199SA SR625170200SA SR625170201SA SR625170202SA SR625170203SA SR625170204SA SR625170205SA SR625170206SA SR625060001SA SR625060002SA SR625060003SA SR625060004SA SR625060005SA SR625060006SA SR625060007SA SR625060008SA SR625060009SA SR625060010SA SR625060011SA SR625060012SA SR625060013SA SR625060014SA SR625060015SA SR625060016SA SR625060017SA SR625060018SA SR625060019SA SR625060020SA SR625060021SA SR625060022SA SR625060023SA SR625060024SA SR625060025SA SR625060026SA SR625060027SA SR625060028SA SR625060029SA SR625060032SA SR625060033SA SR625060034SA SR625060035SA SR625060036SA SR625060037SA SR625060038SA SR625060039SA SR625070040SA SR625070041SA SR625100128SA SR625100129SA SR625110133SA SR625110134SA SR625110135SA SR625080084SA SR625100115SA SR625100116SA SR625100117SA SR625100118SA SR625100119SA SR625100120SA SR625100121SA SR625100122SA SR625100123SA SR625100124SA SR625210228SA SR625210229SA SR625210230SA SR625210231SA SR625210232SA SR625210233SA SR625210234SA SR625210235SA SR625210236SA SR625080086SA SR625130036SA SR625130037SA SR625130038SA SR625130039SA SR625110138SA SR625110139SA SR625070068SA SR625130022SA SR625130023SA SR625210262SA SR625210263SA SR625210264SA SR625130001SA SR625130002SA SR625130003SA SR625130004SA SR625130005SA SR625130006SA SR625130007SA SR625130008SA SR625130009SA SR625130010SA SR625130011SA SR625130012SA SR625120001SA SR625120002SA SR625120003SA SR625070069SA SR625210257SA SR625070042SA SR625070043SA SR625070044SA SR625070045SA SR625070046SA SR625070047SA SR625070066SA SR625070067SA SR625080080SA SR625090089SA SR625090090SA SR625090091SA SR625080085SA SR625080088SA SR625210267SA SR625210258SA SR625210261SA SR625070070SA SR625070071SA SR625070072SA SR625070073SA SR625070074SA SR625070075SA SR625070076SA SR625070077SA SR625070078SA SR625070079SA SR625090092SA SR625090093SA SR625090094SA SR625130013SA SR625130014SA SR625130015SA SR625130016SA SR625130017SA SR625130018SA SR625130019SA SR625130020SA SR625130021SA SR625170157SA SR625240278SA SR625240279SA SR625240280SA SR625240281SA SR625240282SA SR625240283SA SR625250291SA SR625250292SA SR625250293SA SR625250294SA SR625250295SA SR625250296SA SR625250297SA SR625250298SA SR625250299SA SR625250300SA SR625250301SA SR625260316SA SR625260317SA SR625240269SA SR625240270SA SR625240271SA SR625240272SA SR625240273SA SR625240274SA SR625240275SA SR625070048SA SR625070049SA SR625070050SA SR625070051SA SR625070052SA SR625170140SA SR625170141SA SR62517…
UPC codes
00840682147224, 00840682146708

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840682147224
  • 00840682146708

Serial number

On the rating plate, often next to the date of manufacture.

  • s. SR525270031WA SR525270032WA SR52527003
  • s. SR625210256SA SR625200211SA SR62520021

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

GE Healthcare Finland Oy — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: GE Healthcare Finland Oy — Kuortaneenkatu 2, Helsinki

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Healthcare Finland Oy medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840682147224, 00840682146708. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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