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U.S. Department of Health and Human Services

Class 2 Device Recall SERVO Ventilator 300A

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  Class 2 Device Recall SERVO Ventilator 300A see related information
Date Initiated by Firm December 19, 2008
Date Posted February 03, 2009
Recall Status1 Terminated 3 on July 08, 2009
Recall Number Z-0872-2009
Recall Event ID 50676
510(K)Number K970839  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product SERVO Ventilator 300A (SV300A);
Maquet Critical Care Ab, Solna, Sweden.

The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.
Code Information All units of SV300A.
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 Us Highway 22 Ste 202
Bridgewater NJ 08807-2958
For Additional Information Contact Jamie Yieh
732-667-1896
Manufacturer Reason
for Recall		 SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.
FDA Determined
Cause 2		 Device Design
Action URGENT: Device Correction letters were sent out on December 22, 2008. Letters alert users to the potential problem and the situation in which it may occur. Letter indicate the set inspiratory rise time should be set in the range of 7-10% and that the humidifier chamber water level be maintained according to manufacturers instructions. The letter is enclosed as a supplement to the SV300A Operating Manual. Consignees were directed to complete a "Device Correction-Customer Fax Response" to indicate number of units of the affected product and that they followed the instructions for including the attached supplemental instructions to the operating manual. For questions about the recall, contact your local Maquet, Inc. representative.
Quantity in Commerce 3,688 units in US
Distribution 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
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