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U.S. Department of Health and Human Services

Class 2 Device Recall GS70H Salus

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  Class 2 Device Recall GS70H Salus see related information
Date Initiated by Firm August 01, 2023
Date Posted August 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2470-2023
Recall Event ID 92290
Product Classification Table, operating-room, electrical - Product Code GDC
Product GS70H Salus Surgical Table, Product Code 18-071-70
Code Information Serial Numbers:SUC-20207-0002 SUC-20208-0006 SUC-20209-0010 SUC-2020X-0014 SUC-2022Z-0018 SUC-20233-0022 SUC-20207-0003 SUC-20208-0007 SUC-20209-0011 SUC-2020X-0015 SUC-2022Z-0019 SUC-20233-0023 SUC-20208-0004 SUC-20209-0008 SUC-2020X-0012 SUC-2020X-0016 SUC-2022Z-0020 SUC-20233-0024 SUC-20208-0005 SUC-20209-0009 SUC-2020X-0013 SUC-2022Z-0017 SUC-2022Z-0021 SUC-20233-0025
Recalling Firm/
Manufacturer		 Skytron, LLC
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
For Additional Information Contact
616-656-2900
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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