Datex-Ohmeda S/5 Aespire Anesthesia System 7100
FDA device recall Z-0037-06 · posted 2005-10-12 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda Inc
- Reason for recall
- Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.
- Action taken
- Urgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 367
- Distribution
- CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Repu
- Date initiated
- 2005-09-27
- Date posted
- 2005-10-12
- Date terminated
- 2007-04-01
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR (K000706) | Datex-Ohmeda, Inc. | 2000-05-11 |