Z-1441-04

Anestar Anesthesia Delivery System

Name: Z-1441-04 Anestar Anesthesia Delivery System
Creator: Datascope Corp
Published: 2003-06-24
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2003-06-24 / Terminated

FDA source

Datascope Corp began a recall of Anestar Anesthesia Delivery System on 2003-06-24. The reason FDA records is "Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1441-04
Status: Terminated
Initiated: 2003-06-24
Posted: 2004-09-09
Terminated: 2006-10-03
Recalling firm: Datascope Corp.
Product: Anestar Anesthesia Delivery System
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
FDA root cause: Other
Action: A Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.
Distribution: The units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.
Product codes and lots: 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.

Product code BSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)