Class II U.S. Food and Drug Administration

GE Healthcare Finland Oy Portrait VSM Model nos. 6660000-666 Monitor, Physiological 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

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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-0456-2026
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
5990
Distribution
Nationwide
Made in
Finland
Lot / code info
UDI-DI 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA SWP25130724SA SWP25130725SA SWP25130726SA SWP25130727SA SWP25130728SA SWP25130729SA SWP25130730SA SWP25130731SA SWP25130732SA SWP25130733SA SWP25130734SA SWP25130735SA SWP25130736SA SWP25130737SA SWP25130738SA SWP25130739SA SWP25130740SA SWP25130741SA SWP25230019SA SWP25230020SA SWP25230021SA SWP25230022SA SWP25230026SA SWP25210083SA SWP25210084SA SWP25130751SA SWP25130752SA SWP25130753SA SWP25170019SA SWP25170020SA SWP25170021SA SWP25170022SA SWP25170023SA SWP25170024SA SWP25200033SA SWP25200034SA SWP25200035SA SWP25160027SA SWP25180121SA SWP25180122SA SWP25180123SA SWP25230034SA SWP25230035SA SWP25230036SA SWP25250032SA SWP25250033SA SWP25290061SA SWP25260114SA SWP25260115SA SWP25260116SA SWP25260117SA SWP25250046SA SWP25250047SA SWP25250048SA SWP25250050SA SWP25240013SA SWP25120633SA SWP25130746SA SWP25170056SA SWP25250034SA SWP25290065SA SWP25051286SA SWP25110533SA SWP25190088SA SWP25210044SA SWP25260155SA SWP25260156SA SWP25260157SA SWP25260158SA SWP25120623SA SWP25120627SA SWP25130766SA SWP25130843SA SWP25130844SA SWP25151063SA SWP25151071SA SWP25151087SA SWP25170027SA SWP25170028SA SWP25290048SA SWP25290053SA SWP25110399SA SWP25151065SA SWP25180130SA SWP25260120SA SWP25151070SA SWP25180126SA SWP25180127SA SWP25220010SA SWP25300001SA SWP25300002SA SWP25300003SA SWP25300004SA SWP25300005SA SWP25300006SA SWP25300007SA SWP25300008SA SWP25210078SA SWP25220050SA SWP25190090SA SWP25190091SA SWP25190092SA SWP25220063SA SWP25120626SA SWP25210082SA SWP25110389SA SWP25110390SA SWP25120616SA SWP25120617SA SWP25130744SA SWP25130745SA SWP25160028SA SWP25180128SA SWP25220023SA SWP25220024SA SWP25220025SA SWP25220026SA SWP25220027SA SWP25220028SA SWP25220029SA SWP25220030SA SWP25220031SA SWP25220032SA SWP25220034SA SWP25220035SA SWP25220036SA SWP25220037SA SWP25220038SA SWP25220039SA SWP25220040SA SWP25220041SA SWP25220042SA SWP25220043SA SWP25220044SA SWP25220046SA SWP25220047SA SWP25220048SA SWP25220067SA SWP25270075SA SWP25270076SA SWP25130749SA SWP25130750SA SWP25051387SA SWP25051388SA SWP25051389SA SWP25051390SA SWP25090172SA SWP25090173SA SWP25141031SA SWP25141032SA SWP25220018SA SWP25220019SA SWP25220020SA SWP25280039SA SWP25280040SA SWP25200030SA SWP25200031SA SWP25200032SA SWP25090190SA SWP25090191SA SWP25090192SA SWP25090193SA SWP25100013SA SWP25170048SA SWP25250021SA SWP25250022SA SWP25040958SA SWP25040959SA SWP25200017SA SWP25200018SA SWP25200019SA SWP25200020SA SWP25200021SA SWP25200022SA SWP25051391SA SWP25120622SA SWP25230059SA SWP25230060SA SWP25270073SA SWP25280001SA SWP25280002SA SWP25280003SA SWP25280004SA SWP25280005SA SWP25280006SA SWP25280007SA SWP25280008SA SWP25280009SA SWP25280013SA SWP25280014SA SWP25280015SA SWP25280016SA SWP25280017SA SWP25160001SA SWP25160002SA SWP25160003SA SWP25160004SA SWP25160005SA SWP25160006SA SWP25160007SA SWP25160008SA SWP25160009SA SWP25160010SA SWP25160011SA SWP25160012SA SWP25160013SA SWP25160014SA SWP25160015SA SWP25160016SA SWP25160017SA SWP25160019SA SWP25160020SA SWP25160021SA SWP25160022SA SWP25160023SA SWP25160024SA SWP25220049SA SWP25310005SA SWP25040956SA SWP25260102SA SWP25260118SA SWP25290055SA SWP25151080SA SWP25151081SA SWP25270071SA SWP25220065SA SWP25151102SA SWP25151103SA SWP25151104SA SWP25151105SA SWP25151106SA SWP25151107SA SWP25210036SA SWP25210037SA SWP25210038SA SWP25210039SA SWP25210040SA SWP25210041SA SWP25210042SA SWP25210043SA SWP25151088SA SWP25151089SA SWP25151090SA SWP25151091SA SWP25151092SA SWP25151093SA SWP25151094SA SWP25151095SA SWP25151096SA SWP25151097SA SWP25151098SA SWP25151099SA SWP25151100SA SWP25151101SA SWP25110529SA SWP25110530SA SWP25110531SA SWP25120632SA SWP25300062SA SWP25300063SA SWP25130669SA SWP25130670SA SWP25170057SA SWP25240001SA SWP25240002SA SWP25130682SA SWP25130683SA SWP25130684SA SWP25130685SA SWP…
UPC codes
00195278561312

Products covered by this recall

Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms

Check your product

The notice names 3 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.

  • 00195278561312

Model or item number

On the rating label, the box or the instruction sheet.

  • 6660000-666 Monitor

Serial number

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

  • s. SWP25300030SA SWP25300031SA SWP2513071

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 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 00195278561312; model number 6660000-666 Monitor. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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