Recall Z-1844-2016 ยท GDC Table, Operating-Room, Electrical
Skytron, Div. The KMW Group, Inc
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
| Date | May 31, 2016 (initiated Apr 6, 2016) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 458 |
| Distribution | Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.