🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 1, 2023 Skytron Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 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 SUC-2020X-0052 SUC-20227-0071 SUC-20228-0090 SUC-20231-0109 SUC-20208-0015 SUC-20209-0034 SUC-2020X-0053 SUC-20227-0072 SUC-20229-0091 SUC-20231-0110 SUC-20208-0016 SUC-20209-0035 SUC-2020X-0054 SUC-20227-0073 SUC-20229-0092 SUC-20231-0111 SUC-20208-0017 SUC-20209-0036 SUC-2020X-0055 SUC-20227-0074 SUC-20229-0093 SUC-20231-0112 SUC-20208-0018 SUC-20209-0037 SUC-2020Y-0056 SUC-20227-0075 SUC-20229-0094 SUC-20231-0113 SUC-20208-0019 SUC-20209-0038 SUC-2020Y-0057 SUC-20228-0076 SUC-20229-0095 SUC-20231-0114 SUC-20208-0020 SUC-20209-0039 SUC-2020Y-0058 SUC-20228-0077 SUC-2022X-0096 SUC-20231-0115 SUC-20208-0021 SUC-20209-0040 SUC-2020Y-0059 SUC-20228-0078 SUC-2022X-0097 SUC-20208-0022 SUC-20209-0041 SUC-2020Y-0060 SUC-20228-0079 SUC-2022X-0098 SUC-20208-0023 SUC-20209-0042 SUC-20212-0061 SUC-20228-0080 SUC-2022X-0099 SUC-20208-0024 SUC-20209-0043 SUC-20212-0062 SUC-20228-0081 SUC-2022X-0100
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Serial Numbers: 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 SUC-2020X-0052 SUC-20227-0071 SUC-20228-0090 SUC-20231-0109 SUC-20208-0015 SUC-20209-0034 SUC-2020X-0053 SUC-20227-0072 SUC-20229-0091 SUC-20231-0110 SUC-20208-0016 SUC-20209-0035 SUC-2020X-0054 SUC-20227-0073 SUC-20229-0092 SUC-20231-0111 SUC-20208-0017 SUC-20209-0036 SUC-2020X-0055 SUC-20227-0074 SUC-20229-0093 SUC-20231-0112 SUC-20208-0018 SUC-20209-0037 SUC-2020Y-0056 SUC-20227-0075 SUC-20229-0094 SUC-20231-0113 SUC-20208-0019 SUC-20209-0038 SUC-2020Y-0057 SUC-20228-0076 SUC-20229-0095 SUC-20231-0114 SUC-20208-0020 SUC-20209-0039 SUC-2020Y-0058 SUC-20228-0077 SUC-2022X-0096 SUC-20231-0115 SUC-20208-0021 SUC-20209-0040 SUC-2020Y-0059 SUC-20228-0078 SUC-2022X-0097 SUC-20208-0022 SUC-20209-0041 SUC-2020Y-0060 SUC-20228-0079 SUC-2022X-0098 SUC-20208-0023 SUC-20209-0042 SUC-20212-0061 SUC-20228-0080 SUC-2022X-0099 SUC-20208-0024 SUC-20209-0043 SUC-20212-0062 SUC-20228-0081 SUC-2022X-0100

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2469-2023

Related Recalls

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

Skytron

Class I - Dangerous

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.

Aug 1, 2023 Surgical Instruments Nationwide View Details →