Class II — GE Healthcare
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing). |
| Product | GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators. |
| Quantity | 3,213 (437 US, 2,776 OUS) |
| Distribution | Worldwide Distribution. US nationwide, ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, CANADA, CAMEROON, CANDA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, GUATEMALA, HONDURAS, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA… |
| Initiated | 2015-01-27 |
| Classified | 2015-03-13 |
| Terminated | 2016-02-03 |
| Recall number | Z-1270-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare (Z-1270-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70443/
Alerts for GE HealthCare Technologies Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.