Recall Z-2378-2008 ยท FQO Table, Operating-Room, Ac-Powered
Stryker Communications Corp
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.
| Date | Sep 18, 2008 (initiated Jul 2, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.