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U.S. Department of Health and Human Services

Class 2 Device Recall STERIS 4805

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  Class 2 Device Recall STERIS 4805 see related information
Date Initiated by Firm June 27, 2014
Date Posted July 09, 2014
Recall Status1 Terminated 3 on September 16, 2015
Recall Number Z-2026-2014
Recall Event ID 68678
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product The STERIS 4085 General Surgical Table

Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
Code Information All Model Numbers
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Kathryn E. Cadorette
440-392-7601
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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