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.
FDA Recall Z-1313-2010 · Posted 2010-04-08
Recalling FirmMindray DS USA, Inc., dba Datascope Patient Monitoring
Recall StatusTerminated
Product CodeBSZ
Date Initiated2010-03-05
Date Terminated2012-04-25
Product Quantity372 units in US, 107 internationally.
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.
Firm 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].
Root Cause
Other
Distribution Pattern
Worldwide Distribution: USA and Mexico, Columbia, Turks & Caicos Islands, BWI; Ecuador, Bolivia, Peru, Dominican Republic, Netherlands Antilles, Chile.SA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.