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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 24, 2005
Date Posted June 08, 2005
Recall Status1 Terminated 3 on September 08, 2005
Recall Number Z-0878-05
Recall Event ID 31769
510(K)Number K040221  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Servo-i Ventilator
Code Information All Servo-i units with serial numbers below 17617.
Recalling Firm/
Manufacturer		 Maquet Inc
1140 Route 22 East
Bridgewater NJ 08807-2912
For Additional Information Contact Mr. Timmo Bressler
908-947-2303
Manufacturer Reason
for Recall		 Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
FDA Determined
Cause 2		 Other
Action Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i.
Quantity in Commerce 4379 units
Distribution The ventilators were distributed nationwide to hosptials and clinics.
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 = CBK and Original Applicant = MAQUET CRITICAL CARE AB
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