Anestar Anesthesia Delivery System
This recall has been terminated (originally issued September 9, 2004).
- Company
- Datascope Corp.
- Recall Initiated
- June 24, 2003
- Posted
- September 9, 2004
- Terminated
- October 3, 2006
- Recall Number
- Z-1441-04
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
Distribution
The units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.
Lot / Code Info
Serial#: 4600010001; 4600010003; 4600010004; 4600010007; 4600010008; 4600010009; 4600010010; 4600010012; 4600A20017; 4600A20018; 4600A20019; 4600A20020; 4600A20021; 4600A20023; 4600A20024; 4600A30066; 4600A30067; 4600A30068; 4600A30069; 4600A30070; 4600A30071; 4600A30072; 4600A30073; 4600A30074; 4600A30075; 4600B10002; 4600B20025; 4600B20026; 4600B20027; 4600B20028; 4600B20029; 4600B20030; 4600B20031; 4600B20032; 4600B20033; 4600B20034; 4600B30076; 4600B30077; 4600B30078; 4600B30079; 4600B30080; 4600B30081; 4600B30082; 4600B30083; 4600B30084; 4600B30086; 4600C30087; 4600C30088; 4600C30089; 4600C30091; 4600C30092; 4600C30093; 4600C30094; 4600C30095; 4600C30096; 4600C30097; 4600C30098; 4600C30099; 4600D20035; 4600D20036; 4600D20037; 4600D20038; 4600D20039; 4600D20040; 4600D20041; 4600D20042; 4600D20043; 4600D20044; 4600H20045; 4600H20046; 4600H20047; 4600H20048; 4600H20049; 4600H20050; 4600H20051; 4600H20052; 4600H20053; 4600H20054; 4600I10013; 4600J20055; 4600J20056; 4600J20057; 4600J20058; 4600J20059; 4600J20060; 4600J20061; 4600J20062; 4600J20063; 4600J20064.
Root Cause
Other
Action Taken
A Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.