FDA action counts
| Total FDA actions | 19 |
|---|---|
| Warning letters | 0 |
| Recalls | 19 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | November 19, 2025 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. GE Healthcare Finland Oy has 19 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Enforcement history
On 2025-11-19, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600…. On 2025-11-19, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteri…. On 2025-11-19, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: Carescape B450, Model no. 5805686 - shipped with potentially affected batteries…. On 2025-11-19, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With…. On 2025-11-19, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors…. On 2024-07-03, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2)…. On 2024-07-03, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c)…. On 2024-07-03, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2…. On 2024-07-03, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 58…. On 2024-07-03, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "high" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class II recall: CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAE…. On 2023-07-12, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "critical" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class I recall: TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;…. On 2023-07-12, Argus HQ recorded an FDA recall for GE Healthcare Finland Oy, rated "critical" severity in Argus HQ's classification: GE Healthcare Finland Oy — Class I recall: TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, phy….
Frequently asked questions
- How many FDA actions does Argus HQ track for GE Healthcare Finland Oy?
- 19 total: 0 warning letters, 19 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for GE Healthcare Finland Oy?
- November 19, 2025. Argus HQ ingests new FDA enforcement records daily.
- Has GE Healthcare Finland Oy had product recalls?
- Yes, 19 recalls on file. See the full history below for each one.
- Is this FDA enforcement data for GE Healthcare Finland Oy official?
- Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- GE Healthcare Finland Oy — Class II recall: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors… →
- GE Healthcare Finland Oy — Class II recall: Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With… →
- GE Healthcare Finland Oy — Class II recall: Carescape B450, Model no. 5805686 - shipped with potentially affected batteries… →
- GE Healthcare Finland Oy — Class II recall: CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteri… →
- GE Healthcare Finland Oy — Class II recall: B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61600… →
- GE Healthcare Finland Oy — Class II recall: CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAE… →
- GE Healthcare Finland Oy — Class II recall: CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 58… →
- GE Healthcare Finland Oy — Class II recall: CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2… →
- GE Healthcare Finland Oy — Class II recall: CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c)… →
- GE Healthcare Finland Oy — Class II recall: CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2)… →
Compare with
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Nov 19, 2025Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). GE Healthcare Finland Oy's Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/ge-healthcare-finland-oy
"GE Healthcare Finland Oy's Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/ge-healthcare-finland-oy.
Argus HQ Research. "GE Healthcare Finland Oy's Complete FDA Record." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/ge-healthcare-finland-oy.
@misc{argushq_argushq_ai_company_ge_healthcare_finland_oy_2025,
title = {GE Healthcare Finland Oy's Complete FDA Record},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/ge-healthcare-finland-oy},
note = {Accessed: July 17, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗