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U.S. Department of Health and Human Services

Class 2 Device Recall SV900C/D/E (SV900)

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 Class 2 Device Recall SV900C/D/E (SV900)see related information
Date Initiated by FirmNovember 17, 2009
Date PostedJanuary 05, 2010
Recall Status1 Terminated 3 on June 04, 2012
Recall NumberZ-0589-2010
Recall Event ID 53843
510(K)NumberK871254 K884520 
Product Classification ventilator - Product Code CBK
ProductMaquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
Code Information Serial Numbers 010001-188499 Ventilators within the specified serial number range, that are marked with one of the following labels on the inside of the lid of the pneumatic unit are exempted since they have already been fitted with a new type of the pressure transducer. 1. Upgrade EMO 12/02/1; 2. Upgrade SV300 6682-745  SV900 66 82 747.
Recalling Firm/
Manufacturer		 MAQUET Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information ContactJames Molloy
973-709-7227
Manufacturer Reason
for Recall		Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
FDA Determined
Cause 2		Device Design
ActionMaquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
Quantity in Commerce29364 (8438 of those in US)
DistributionWorldwide distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CBK
510(K)s with Product Code = CBK
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