Recall Z-0196-2015 ยท GDC Table, Operating-Room, Electrical
Steris Corporation
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
| Date | Nov 7, 2014 (initiated Oct 10, 2014) |
| Status | Terminated |
| Reason | The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table. |
| Root cause | Device Design |
| Action | STERIS will mail Consignee Notification Letters to the affected Consignees via FedEx with tracking numbers for delivery confirmation. The Consignee Notification mailing will initiate the week of October 13, 2014. |
| Quantity | 999 |
| Distribution | US distribution: AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI. Foriegn: Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090136 | STERIS CMAX XLT SURGICAL TABLE STERIS Corporation, Mar 20, 2009 |