GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x a
FDA device recall Z-0784-2007 · posted 2007-05-10 · Terminated
Recall details
- Recalling firm
- Datex - Ohmeda, Inc
- Reason for recall
- There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.
- Action taken
- Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 446
- Distribution
- GA, RI, WI, TX. Foreign - AUSTRALIA, BRUNEI DARUSSALAM, BRAZIL, COLOMBIA, COSTA RICA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDIA, ITALY, KOREA, MEXICO, MALAYSIA, PHILIPPINES, SAUDI ARABIA, SWEDEN,
- Date initiated
- 2007-02-02
- Date posted
- 2007-05-10
- Date terminated
- 2008-10-16
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K060862) | Datex-Ohmeda, Inc. | 2006-06-05 |