Recall Z-0929-06 ยท BSZ Gas-Machine, Anesthesia
Datascope Corp
Anestar and Anestar Plus Anesthesia System.
| Date | Jun 2, 2006 (initiated Mar 17, 2006) |
| Status | Terminated |
| Reason | The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve. |
| Root cause | Other |
| Action | Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required. |
| Quantity | 337 UNITS |
| Distribution | The units have been distributed to distributors and end-users such as hospitals and clinics nationwide. There are 3 foreign accounts in Australia, El Salvador, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001988 | MODULAR Heyer America, Inc., Feb 5, 2001 |