FDA Medical Device Recalls (openFDA)
Datascope Corp: Anestar Anesthesia Delivery System
- Recall number
- Z-1441-04
- Recalling firm
- Datascope Corp
- Product
- Anestar Anesthesia Delivery System
- Status
- Terminated
- Initiated
- 2003-06-24
- Posted
- 2004-09-09
- Terminated
- 2006-10-03
- Reason
- Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
- Root cause
- Other
- Action
- A Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.
- Quantity
- not on file
- Distribution
- The units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28