Terminated

The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

FDA Recall Z-2026-2014 · Posted 2014-07-09

Recalling FirmSteris Corporation

Recall StatusTerminated

Product CodeFQO

Date Initiated2014-06-27

Date Terminated2015-09-16

Product Quantity3689

Reason for Recall

STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.

Firm Action

STERIS sent an Urgent Voluntary Field Correction Noticel letter dated June 27, 2014 to affected Customers.via FedEx with tracking numbers for delivery confirmation. The letter identified the description of the product, description of the problem and the actions to be taken. For questions contact Steris Field Service Dispatch at 1-800-333-8828.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide in the states of AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam, China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.

Official Source

View FDA Recall →

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