Reported Sep 6, 2023 · Ongoing
GS70 Salus Surgical Table, Product Code 18-070-70
Skytron, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Skytron, LLC · 5085 Corporate Exchange Blvd SE · Grand Rapids, MI · 49512-5515
Is this the product you have?
GS70 Salus Surgical TableProduct Code 18-070-70
- Lot codes and dates
- Serial Numbers
110 of 110 codes
SUC-20207-0006SUC-20208-0025SUC-20209-0044SUC-20212-0063SUC-20228-0082SUC-2022Y-0101SUC-20207-0007SUC-20208-0026SUC-20209-0045SUC-20212-0064SUC-20228-0083SUC-2022Y-0102SUC-20207-0008SUC-20208-0027SUC-2020X-0046SUC-20212-0065SUC-20228-0084SUC-2022Y-0103SUC-20207-0009SUC-20208-0028SUC-2020X-0047SUC-20226-0066SUC-20228-0085SUC-2022Y-0104SUC-20207-0010SUC-20208-0029SUC-2020X-0048SUC-20226-0067SUC-20228-0086SUC-2022Y-0105SUC-20207-0011SUC-20209-0030SUC-2020X-0049SUC-20226-0068SUC-20228-0087SUC-20231-0106SUC-20207-0012SUC-20209-0031SUC-2020X-0050SUC-20226-0069SUC-20228-0088SUC-20231-0107SUC-20207-0013SUC-20209-0032SUC-2020X-0051SUC-20226-0070SUC-20228-0089SUC-20231-0108SUC-20208-0014SUC-20209-0033SUC-2020X-0052SUC-20227-0071SUC-20228-0090SUC-20231-0109SUC-20208-0015SUC-20209-0034SUC-2020X-0053SUC-20227-0072SUC-20229-0091SUC-20231-0110
- Serial Numbers
- Amount recalled
- 110 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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