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U.S. Department of Health and Human Services

Class 2 Device Recall ServoVentilator

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  Class 2 Device Recall ServoVentilator see related information
Date Initiated by Firm January 03, 2005
Date Posted March 08, 2005
Recall Status1 Terminated 3 on September 08, 2005
Recall Number Z-0571-05
Recall Event ID 30765
510(K)Number K902859  K970839  
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
Code Information All units with the Serial Numbers 24578 and lower. Total of 7920 units.
Recalling Firm/
Manufacturer		 Maquet Inc
1140 Route 22 East
Bridgewater NJ 08807-2912
For Additional Information Contact Mr. Jamie Yieh
908-947-2311
Manufacturer Reason
for Recall		 Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
FDA Determined
Cause 2		 Other
Action Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.
Quantity in Commerce 7920 units
Distribution The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.
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 = SIEMENS ELEMA AB
510(K)s with Product Code = CBK and Original Applicant = SIEMENS LIFE SUPPORT SYSTEMS
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