Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow i
FDA device recall Z-1313-2010 · posted 2010-04-08 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 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
- Date initiated
- 2010-03-05
- Date posted
- 2010-04-08
- Date terminated
- 2012-04-25
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 (K080175) | Datascope Corp., Patient Monitoring Division | 2008-06-09 |