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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Thoratec Dual Drive Console		see related information
Date Posted February 10, 2007
Recall Number Z-0412-2007
Product Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Code Information All Dual Drive Consoles manufactured before July 10, 2002 with serial numbers between 301 and 636, inclusive
Recalling Firm/
Manufacturer		 Thoratec Corp
6035 Stoneridge Drive
Pleasanton, California 94588
For Additional Information Contact Gary D. Cederwall
925-730-4118
Reason for
Recall		 The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.
Action The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches.
Quantity in Commerce 331
Distribution Worldwide
 
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