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fda_recall · device_recall · high

GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600…

Event date
2025-11-19 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-0455-2026
Payload hash
40fb188a33ba52aa0d95fcd8

Summary

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… Status: Ongoing.

Frequently asked questions

Has GE Healthcare Finland Oy had other FDA enforcement actions?
Yes. Argus HQ has recorded 19 total FDA actions tied to GE Healthcare Finland Oy: 0 warning letters, 19 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2025-11-19; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2025). GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-0455-2026
MLA
"GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-0455-2026.
Chicago
Argus HQ Research. "GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-0455-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_finland_oy_z_0455_2026_2025,
  title = {GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-0455-2026},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.