EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table

FDA device recall Z-1844-2016 · posted 2016-05-31 · Terminated

Recall details

Recalling firm

Skytron, Div. The KMW Group, Inc

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.

Action taken

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.

Root cause

Reprocessing Controls

Status

Terminated

Product code

GDC

Quantity affected

458

Distribution

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

Date initiated

2016-04-06

Date posted

2016-05-31

Date terminated

2017-07-20

Location

Grand Rapids, MI