The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal tab
FDA device recall Z-0196-2015 · posted 2014-11-07 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GDC
- Quantity affected
- 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, Br
- Date initiated
- 2014-10-10
- Date posted
- 2014-11-07
- Date terminated
- 2015-06-26
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERIS CMAX XLT SURGICAL TABLE (K090136) | STERIS Corporation | 2009-03-20 |