GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1
FDA device recall Z-1270-2015 · posted 2015-03-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated January 26, 2015, Ref#34063. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171, or your local Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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
- Date initiated
- 2015-01-27
- Date posted
- 2015-03-24
- Date terminated
- 2016-02-03
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 (K111116) | Datex-Ohmeda | 2011-09-09 |