Z-0319-2009

AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a...

Name: Z-0319-2009 AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a...
Creator: Mindray DS USA, Inc., dba Datascope Patient Monitoring
Published: 2008-10-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2008-10-07 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc., dba Datascope Patient Monitoring began a recall of AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously... on 2008-10-07. The reason FDA records is "Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0319-2009
Status: Terminated
Initiated: 2008-10-07
Posted: 2008-12-05
Terminated: 2008-12-08
Recalling firm: Datascope Corp.
Product: AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate
Root cause tag: design
FDA root cause: Component design/selection
Action: Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
Quantity in commerce: 2 units
Distribution: Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
Product codes and lots: Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.

Product code BSZ

K080175Class IINavigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division / cleared 2008-06-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)