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.
FDA Recall Z-2378-2008 · Posted 2008-09-18
Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeFQO
Date Initiated2008-07-02
Date Terminated2010-01-07
Product Quantity18 units.
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.