| | Class 2 Recall
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 |  |
| Date Posted |
April 08, 2010 |
| Recall Number |
Z-1313-2010 |
| 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. |
| Code Information |
Product numbers 0998-00-3024-01.
|
Recalling Firm/
Manufacturer |
Mindray DS USA, Inc., dba Datascope Patient Monitoring
800 Macarthur Blvd
Mahwah, New Jersey 07430 |
| For Additional Information Contact |
Thomas Barford
201-995-8391
|
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 |
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 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 |
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