Recall Z-1270-2015 ยท CBK Ventilator, Continuous, Facility Use
GE Healthcare
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.
| Date | Mar 24, 2015 (initiated Jan 27, 2015) |
| Status | Terminated |
| Reason | Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing). |
| Root cause | Device Design |
| Action | 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. |
| 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, GUA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 Datex-Ohmeda, Sep 9, 2011 |