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U.S. Department of Health and Human Services

Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 099800302401

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 Class 2 Recall
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 099800302401
see related information
Date Posted April 08, 2010
Recall Status1 Terminated on April 25, 2012
Recall Number Z-1313-2010
Recall Event ID 54851
Premarket Notification
510(K) Number
K080175 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
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
Manufacturer 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 Determined
Cause 2
OTHER/UNDETERMINED: Pending
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATASCOPE CORP., PATIENT MONITORING DIVISION
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