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Terminated

The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.

FDA Recall Z-0196-2015 · Posted 2014-11-07

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeGDC
Date Initiated2014-10-10
Date Terminated2015-06-26
Product Quantity999

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.

Firm 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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090136STERIS CMAX XLT SURGICAL TABLESTERIS Corporation · 2009-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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