Recall Z-2470-2023 ยท GDC Table, Operating-Room, Electrical
Skytron, LLC
GS70H Salus Surgical Table, Product Code 18-071-70
| Date | Aug 28, 2023 (initiated Aug 1, 2023) |
| Status | Open, Classified |
| Reason | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the |
| Root cause | Under Investigation by firm |
| Action | An URGENT: Medical Device Correction dated 7/25/23 was sent to customers. Actions to be taken by the user: 1. Please promptly forward this notification if the device has been transferred to any other entity. 2. Please review appendices of affected serial and UDI numbers and identify devices within your facility. 3. Please do not use the table control in Bluetooth mode until the correction has been installed. 4. Please contact quality at quality@skytron.com with any questions. Skytron authorized service technicians will contact affected facilities to schedule this service. A location with a m |
| Quantity | 24 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, MA, MI, MO, PA, TN, TX, UT, WA, WI and the countries of Australia, New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.