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U.S. Department of Health and Human Services

Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM

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 Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEMsee related information
Date Initiated by FirmOctober 07, 2008
Date PostedDecember 05, 2008
Recall Status1 Terminated 3 on December 08, 2008
Recall NumberZ-0319-2009
Recall Event ID 49713
510(K)NumberK080175 
Product Classification Anesthesia gas-machine - Product Code BSZ
ProductAS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
Code Information Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc., dba Datascope Patient Monitoring
800 Macarthur Blvd
Mahwah NJ 07430
For Additional Information ContactThomas W. Barford
201-995-8391
Manufacturer Reason
for Recall		Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate
FDA Determined
Cause 2		Component design/selection
ActionNotification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
Quantity in Commerce2 units
DistributionOnly 2 units are in distribution, both in the same facility in Redondo Beach, CA.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = BSZ
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