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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 Recall
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Date Posted May 12, 2009
Recall Status1 Terminated on November 16, 2009
Recall Number Z-1252-2009
Recall Event ID 51473
Premarket Notification
510(K) Numbers
K902859  K970839 
Product Classification Ventilator, Continuous, 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/
1140 US Highway 22
Bridgewater, New Jersey 08807-2958
For Additional Information Contact Jamie Yieh
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
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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