Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall NAVIGATOR ANESTHESIA DELIVERY SYSTEM see related information
Date Initiated by Firm October 07, 2008
Date Posted December 05, 2008
Recall Status1 Terminated 3 on December 08, 2008
Recall Number Z-0319-2009
Recall Event ID 49713
510(K)Number K080175  
Product Classification Anesthesia gas-machine - Product Code BSZ
Product AS3000 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 Contact Thomas 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
Action Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
Quantity in Commerce 2 units
Distribution Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = BSZ and Original Applicant = DATASCOPE CORP., PATIENT MONITORING DIVISION
-
-