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U.S. Department of Health and Human Services

Class 2 Device Recall Servoi Ventilator Systems

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  Class 2 Device Recall Servoi Ventilator Systems see related information
Date Initiated by Firm April 20, 2011
Date Posted June 23, 2011
Recall Status1 Terminated 3 on September 17, 2013
Recall Number Z-2628-2011
Recall Event ID 58793
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Servo-i Ventilator Systems; Article number 64 87 800

Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents.
Code Information Article number 64 87 800; all units
Recalling Firm/
Manufacturer
Maquet Inc.
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Mrs. Whitney Torning
973-709-7994
Manufacturer Reason
for Recall
Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes.
FDA Determined
Cause 2
Other
Action Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.
Quantity in Commerce 43210 units worlwide, 14412 units in the US
Distribution Worldwide Distribution - USA (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.
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