Recall Z-1313-2010 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc., dba Datascope Patient Monitoring
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
| Date | Apr 8, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | 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. |
| 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 k.maine@mindray.com. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080175 | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 Datascope Corp., Patient Monitoring Division, Jun 9, 2008 |