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U.S. Department of Health and Human Services

Class 2 Device Recall Servoi ventilator system

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  Class 2 Device Recall Servoi ventilator system see related information
Date Initiated by Firm December 22, 2011
Date Posted April 03, 2012
Recall Status1 Terminated 3 on October 22, 2013
Recall Number Z-1362-2012
Recall Event ID 61327
510(K)Number K041223  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Servo-i ventilator system

Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Code Information 510k k041223 B052264 Article 64 87 800 Serial numbers 56001-58411
Recalling Firm/
Manufacturer		 Maquet Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Whitney Torning
973-709-7994
Manufacturer Reason
for Recall		 The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
FDA Determined
Cause 2		 Device Design
Action Maquet sent a Product Recall Urgent-Medical Device Corrective Action letter dated December 22, 2011 to all affected customers. The letter identified the affected products, patient risk, product issue and actions to be taken. Customers were instructed to complete and return the attached Customer Fax Response form as soon as possible. Maquet Field Service Technicians will update all affected products at all the concerned customer sites. Customers are advised untill Maquet has updated all the affected products (all of which are still under warranty), inform all the concerned biomedical staff about the content of this Device Correction Letter. For technical support call 1-888-627-8383.
Quantity in Commerce 647 US; 2462 Foreign; 27 Spare Parts Foreign
Distribution USA 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 = MAQUET CRITICAL CARE AB
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