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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron EZ Slide Operating Table

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  Class 2 Device Recall Skytron EZ Slide Operating Table see related information
Date Initiated by Firm April 06, 2016
Date Posted May 31, 2016
Recall Status1 Terminated 3 on July 20, 2017
Recall Number Z-1844-2016
Recall Event ID 74128
Product Classification Table, operating-room, electrical - Product Code GDC
Product EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide
General Purpose Surgical Table

Skytron EZ Slide Operating Table
General Purpose Surgical Table
Code Information Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014
Recalling Firm/
Manufacturer		 Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
For Additional Information Contact Thao Selleck
616-656-6403
Manufacturer Reason
for Recall		 The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.
FDA Determined
Cause 2		 Reprocessing Controls
Action Skytron sent an Urgent Medical Device Recall letter dated A,pril 4, 2016, to all affected customers. On April 6, 2016, URGENT: Medical Device Recall notifications were sent to the affected hospitals and distributors via certified mail. The notification instructed the hospital to identify and remove the affected product from use. The notification instructs the distributor to contact the hospital to schedule replacement. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. The notification did not include instructions for responding to the formal recall notification, however the company did request acknowledgement via follow-up email. Please call Technical Services, at 616-656-1187 or 616-656-6403 with any questions. For after-hours support, please call 1-800-SKYTRON.
Quantity in Commerce 458
Distribution Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.
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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