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U.S. Department of Health and Human Services

Class 2 Device Recall SERVO VENTILATOR 300

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  Class 2 Device Recall SERVO VENTILATOR 300 see related information
Date Initiated by Firm March 23, 2009
Date Posted May 12, 2009
Recall Status1 Terminated 3 on November 16, 2009
Recall Number Z-1252-2009
Recall Event ID 51473
510(K)Number K902859  K970839  
Product Classification Continuous ventilator, facility use - Product Code CBK
Product Servo Ventilator 300 (Model SV300) and
Servo Ventilator 300 (Model SV300A).

The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
Code Information All units manufactured prior to June 2002.
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater NJ 08807-2958
For Additional Information Contact Jamie Yieh
732-667-1898
Manufacturer Reason
for Recall		 The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
FDA Determined
Cause 2		 Device Design
Action An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.
Quantity in Commerce 7,847 units
Distribution Nationwide Distribution.
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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