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New Search Back To Search Results   Medical Device Recalls Class 2 Recall SERVO-i Date Recall Initiated May 23, 2006 Date Posted January 25, 2007 Recall Number Z-0372-2007 Product Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care Code Information Article # 64-87-800 Serial numbers 02400 - 03300 Recalling Firm/ Manufacturer MAQUET Inc. 1140 US Highway 22 Bridgewater , New Jersey 08807-2958 For Addition Information Contact Jamie Yieh 908-947-2311 Reason For Recall Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned. Action Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications. Quantity in Commerce 1, 970 units Distribution Worldwide

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