Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER...
Stryker Communications Corp began a recall of Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications... on . The reason FDA records is "Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2189-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- STRYKER Communications, Inc.
- Product
- Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient.
- Product code
- FQO Table, Operating-Room, Ac-Powered
- Reason for recall
- Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Firm notified consignees via letter titled URGENT: Device Recall, dated 04/01/08. Consignees notified of issue and were told a company representative would visit the firm to perform the required maintenance. Contact Karen Smith-Mosley at 972-410-7310 if you have questions.
- Quantity in commerce
- 10 units.
- Distribution
- Nationwide distribution to the following states: CA, CO, TX and UT.
- Product codes and lots
- Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; and 071019-38649.
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