The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to su

FDA device recall Z-2026-2014 · posted 2014-07-09 · Terminated

Recall details

Recalling firm

Steris Corporation

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.

Action taken

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

Status

Terminated

Product code

FQO

Quantity affected

3689

Distribution

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, O

Date initiated

2014-06-27

Date posted

2014-07-09

Date terminated

2015-09-16

Location

Mentor, OH