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Medical Device Recalls
Class 2 Recall
SERVO-s Ventilator System

See Related Information
Date Recall
Initiated		 July 08, 2008
Date Posted September 23, 2008
Recall Number Z-2443-2008
Product SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Code Information Article Number: 66-40-440 Serial numbers: 7591, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7613 through 7666, 7676, 7677, 7678, 7879, 7680, 7681, 7682, 7686 through 7703, 7709 through 7724, 7737, 7740, 7745, 7749, 7750, 7758, 7759, 7760, 7763, 7764, 7770, 7771, 7772, 7775, 7776, 7777, 7778, 7779, 7800 through 7825
Recalling Firm/
Manufacturer		 MAQUET Inc.
1140 US Highway 22
Bridgewater , New Jersey 08807-2958
For Addition Information Contact Jamie Yieh
732-667-1896
Reason For
Recall		 Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
Action Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
Quantity in Commerce 122 total (SERVO-i and SERVO-s) in US.
Distribution Worldwide.
 

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