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U.S. Department of Health and Human Services

Class 2 Device Recall STERIS 5085 and 5085SRT Surgical Table

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  Class 2 Device Recall STERIS 5085 and 5085SRT Surgical Table see related information
Date Initiated by Firm October 10, 2014
Date Posted November 07, 2014
Recall Status1 Terminated 3 on June 26, 2015
Recall Number Z-0196-2015
Recall Event ID 69472
510(K)Number K090136  
Product Classification Table, operating-room, electrical - Product Code GDC
Product The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
Code Information 5085 and 5085SRT
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Kathryn Cadorette
440-392-7601
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 999
Distribution 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.
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.
510(K) Database 510(K)s with Product Code = GDC and Original Applicant = STERIS Corporation
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