GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, an
FDA device recall Z-1829-2008 · posted 2008-09-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while the nebulizer is active, may result in the discontinuance of mechanical ventilation. This issue affects all of the Engstrm Carestations shipped between 12/4/2006
- Action taken
- Consignees were sent a "GE Urgent Medical Device Correction" letter on 5/12/08 addressed to Health Care Administrator/Risk Manger, Chief of Intensive Care & Director of Clinical Engineering. The letter described the affected product and the problem and provided a short term recommendation and a long term solution which included installation of a revised board on all affected Engstrom Carestations. A GE Healthcare Field Service Engineer to contact the facility to schedule the update. If you have questions, contact Melissa Davis at GE Healthcare at 1-800-345-2700 extension 3439.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 1130
- Distribution
- WI, GA, SC, TX, RI, NY, NM, IN VIETNAM, VENEZULA, UNITED KINGDOM, TURKEY, KOREA, JAPAN, ITALY, INDIA, ICELAND, HONG KONG, GREECE, GERMANY, GEORGIA, FRANCE, TUNISIA, THAILAND, SWITZERLAND, SPAIN, SOUTH
- Date initiated
- 2008-04-23
- Date posted
- 2008-09-24
- Date terminated
- 2012-05-16
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K062710) | Datex-Ohmeda, Inc. | 2006-12-08 |