ClearanceBrief
Recall Z-1441-04 ยท BSZ Gas-Machine, Anesthesia

Datascope Corp

Anestar Anesthesia Delivery System

DateSep 9, 2004 (initiated Jun 24, 2003)
StatusTerminated
ReasonFailure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
Root causeOther
ActionA Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.
DistributionThe units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.