Device product
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
Z-0196-2015
Product summary
- Event
- Event 69472
- Status
- Terminated
- Classification
- Class II
- Quantity
- 999
- Official record key
device-enforcement:Z-0196-2015
Official wording
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.
Code information: 5085 and 5085SRT
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.