Z-1313-2010

Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a...

Name: Z-1313-2010 Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a...
Creator: Mindray DS USA, Inc., dba Datascope Patient Monitoring
Published: 2010-03-05
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2010-03-05 / Terminated

FDA source

Mindray DS USA, Inc., dba Datascope Patient Monitoring began a recall of Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that... on 2010-03-05. The reason FDA records is "An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1313-2010
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-04-08
Terminated: 2012-04-25
Recalling firm: Datascope Corp.
Product: Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
FDA root cause: Other
Action: An "URGENT PRODUCT FIELD CORRECTIVE ACTION" letter dated March 5, 2010 was sent certified mail to all facilities/customers that have the AS3000 units. The letter described the product, problem and corrective Action/remediation by the firm. A Mindray Service Representative will contact the customers to arrange for the caster mounts to be replaced on the AS3000 units in their facilities at no cost. If you have any questions, please contact Karen Maine of the Mindray DS USA, Inc. Marketing Department at 201-995-8612 or [email protected].
Quantity in commerce: 372 units in US, 107 internationally.
Distribution: Worldwide Distribution: USA and Mexico, Columbia, Turks & Caicos Islands, BWI; Ecuador, Bolivia, Peru, Dominican Republic, Netherlands Antilles, Chile.SA
Product codes and lots: Product numbers 0998-00-3024-01.

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)