FDA Recall Terminated

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

Recall: Z-1844-2016 · Initiated April 6, 2016

Recall

Recall Number: Z-1844-2016
Event Number: 74128
Firm: Skytron, Div. The KMW Group, Inc
FEI Number: 1825014
Product Code: GDC
Status: Terminated
Root Cause: Reprocessing Controls
Initiated: April 6, 2016
Posted: May 31, 2016
Terminated: July 20, 2017
Address: 5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

Description

Reason

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.

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.

Distribution

Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.

Quantity

458