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Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 099800302401 |
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Date Initiated by Firm |
March 05, 2010 |
Date Posted |
April 08, 2010 |
Recall Status1 |
Terminated 3 on April 25, 2012 |
Recall Number |
Z-1313-2010 |
Recall Event ID |
54851 |
510(K)Number |
K080175
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Product Classification |
gas-machine, anesthesia - Product Code BSZ
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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 NJ 07430
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For Additional Information Contact |
Thomas Barford 201-995-8391
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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.
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FDA Determined Cause 2 |
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 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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = BSZ and Original Applicant = DATASCOPE CORP., PATIENT MONITORING DIVISION
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