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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Skytron, LLC: GS70 and GS70H Surgical Tables Recalled Due to Unexpected Movement Risk

Agency Publication Date: August 28, 2023
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Summary

Skytron, LLC is recalling 134 GS70 Salus and GS70H Salus Surgical Tables because the tables may continue to move even after the control button is released. This defect occurs when communication between the hand-held control pendant and the table is interrupted while a button is being pressed, affecting both Bluetooth wireless and wired connection modes. The recall affects 110 units of the GS70 model and 24 units of the GS70H model distributed worldwide and across several U.S. states. Consumers should contact their healthcare provider or the manufacturer to ensure their equipment is functioning correctly and to receive further instructions on necessary updates or repairs.

Risk

If the table continues to move unexpectedly during a medical procedure, it could lead to patient injury, unintended surgical outcomes, or harm to clinical staff. The device fails to recognize that a command has ended if the signal is lost mid-press, causing the table to continue its last motorized action.

What You Should Do

  1. Identify if your surgical table is affected by checking the model and serial numbers located on the device chassis.
  2. For GS70 Salus Surgical Tables (Product Code 18-070-70), check for serial numbers: SUC-20207-0006 through SUC-20207-0013, SUC-20208-0014 through SUC-20208-0029, SUC-20209-0030 through SUC-20209-0045, SUC-2020X-0046 through SUC-2020X-0055, SUC-2020Y-0056 through SUC-2020Y-0060, SUC-20212-0061 through SUC-20212-0065, SUC-20226-0066 through SUC-20226-0070, SUC-20227-0071 through SUC-20227-0075, SUC-20228-0076 through SUC-20228-0090, SUC-20229-0091 through SUC-20229-0095, SUC-2022X-0096 through SUC-2022X-0100, SUC-2022Y-0101 through SUC-2022Y-0105, and SUC-20231-0106 through SUC-20231-0115.
  3. For GS70H Salus Surgical Tables (Product Code 18-071-70), check for serial numbers: SUC-20207-0002, SUC-20207-0003, SUC-20208-0004 through SUC-20208-0007, SUC-20209-0008 through SUC-20209-0011, SUC-2020X-0012 through SUC-2020X-0016, SUC-2022Z-0017 through SUC-2022Z-0021, and SUC-20233-0022 through SUC-20233-0025.
  4. Contact Skytron, LLC at their Grand Rapids headquarters or through your authorized distributor to arrange for a service technician to address the communication failure software issue.
  5. Report any incidents of unexpected table movement or related injuries to your facility's safety officer and the manufacturer immediately.
  6. For additional questions or to report safety concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software or mechanical investigation and corrective action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GS70 Salus Surgical Table
Model / REF:
18-070-70
Lot Numbers (110):
SUC-20207-0006
SUC-20208-0025
SUC-20209-0044
SUC-20212-0063
SUC-20228-0082
SUC-2022Y-0101
SUC-20207-0007
SUC-20208-0026
SUC-20209-0045
SUC-20212-0064
SUC-20228-0083
SUC-2022Y-0102
SUC-20207-0008
SUC-20208-0027
SUC-2020X-0046
SUC-20212-0065
SUC-20228-0084
SUC-2022Y-0103
SUC-20207-0009
SUC-20208-0028
SUC-2020X-0047
SUC-20226-0066
SUC-20228-0085
SUC-2022Y-0104
SUC-20207-0010
SUC-20208-0029
SUC-2020X-0048
SUC-20226-0067
SUC-20228-0086
SUC-2022Y-0105
SUC-20207-0011
SUC-20209-0030
SUC-2020X-0049
SUC-20226-0068
SUC-20228-0087
SUC-20231-0106
SUC-20207-0012
SUC-20209-0031
SUC-2020X-0050
SUC-20226-0069
SUC-20228-0088
SUC-20231-0107
SUC-20207-0013
SUC-20209-0032
SUC-2020X-0051
SUC-20226-0070
SUC-20228-0089
SUC-20231-0108
SUC-20208-0014
SUC-20209-0033
Product: GS70H Salus Surgical Table
Model / REF:
18-071-70
Lot 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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92290
Status: Active
Manufacturer: Skytron, LLC
Sold By: Skytron, LLC; Mizuho; authorized medical equipment distributors
Manufactured In: United States
Units Affected: 2 products (110 units; 24 units)
Distributed To: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Michigan, Missouri, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.