OR table TITAN, Surgical Table. Surgical bed with Orthopedic Accessories.
FDA device recall Z-0394-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Trumpf Medical Systems, Inc.
- Reason for recall
- Product is being recalled due to unintended movement on the Titan Tables.
- Action taken
- Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FQO
- Quantity affected
- 94 beds total for all types.
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-01-21
- Date posted
- 2012-01-11
- Date terminated
- 2012-08-13
- Location
- Charleston, SC
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