Drug & Device Safety Atlas
Class II FDA device recall · Z-2470-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

GS70H Salus Surgical Table, Product Code 18-071-70

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm
Skytron, LLC
Product type
Devices
Recall number
Z-2470-2023
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Grand Rapids, MI
Recall initiated
2023-08-01

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2470-2023 · Source: openFDA enforcement.