VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled standard table); distributed by Stryker...
Stryker Communications Corp began a recall of VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled standard table); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered... on . The reason FDA records is "Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2378-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- STRYKER Communications, Inc.
- Product
- VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled standard table); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.
- Product code
- FQO Table, Operating-Room, Ac-Powered
- Reason for recall
- Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence.
- Quantity in commerce
- 18 units.
- Distribution
- Nationwide Distribution --- including states of AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC.
- Product codes and lots
- All lot codes/serial numbers.
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