Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005,
FDA device recall Z-0412-2007 · posted 2007-02-10 · Terminated
Recall details
- Recalling firm
- Thoratec Corp
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 331
- Distribution
- Worldwide
- Date initiated
- 2004-09-24
- Date posted
- 2007-02-10
- Date terminated
- 2008-04-18
- Location
- Pleasanton, CA
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