Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is design
FDA device recall Z-1196-06 · posted 2006-07-12 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output.
- Action taken
- An Urgent Medical Device Correction letter dated March 21, 2006, was sent to customers. It warns of the potential for no anesthetic agent output. The letter contains short term recommendations for use of the device until a GE Healthcare representative contacts the facility to schedule a vist and implelment corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 62
- Distribution
- World wide-(including the States of IA, CA, MI, FL, MI, TX, IL, WI, OH, and countries of Finland, Singapore, Austria, South Africa, Sweden, Israel, Norway, Taiwan, Germany, Turkey, Portugal, Italy, Sw
- Date initiated
- 2006-03-22
- Date posted
- 2006-07-12
- Date terminated
- 2007-05-29
- 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 |
|---|---|---|
| AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) (K973985) | Datex-Engstrom, Inc. | 1998-10-30 |