FDA Recall
Terminated
Datex-Ohmeda S/5 Anesthesia Delivery Units
Recall: Z-0937-03
·
Initiated July 15, 2003
Recall
- Recall Number
- Z-0937-03
- Event Number
- 26765
- Firm
- Datex-Ohmeda Inc One Ohmeda
- FEI Number
- 2183066
- Product Code
- BSZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 15, 2003
- Posted
- August 28, 2003
- Terminated
- November 8, 2005
- Address
- Dr. Box 7550, Madison, WI, 53707
Description
Datex-Ohmeda S/5 Anesthesia Delivery Units
Reason
Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
Action
Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.
Distribution
The product was distributed nationwide to hospitals in the Unites States.
Quantity
544 units