GS70 Salus Surgical Table, Product Code 18-070-70

FDA device recall Z-2469-2023 · posted 2023-08-28 · Open, Classified

Recall details

Recalling firm

Skytron, LLC

Reason for recall

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 table does not know if/when a button is released. This occurs in wireless or wired mode.

Action taken

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 medical outlet and a power cord for the operating table available will be required to complete the corrective action. Skytron estimates that this correction activity will be completed by December 31, 2023. Please do not use the table control in Bluetooth mode until the correction has been installed.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GDC

Quantity affected

110 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.

Date initiated

2023-08-01

Date posted

2023-08-28

Location

Grand Rapids, MI