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Serious riskFDA DeviceClass II

Baxter TruSystem 7500 operating table recalled for lift drop risk

The main lift on the TruSystem 7500 Hybrid Plus (FC) operating table column may unexpectedly drop from its set position to its lowest position during use, and the tabletop could not be raised again after a drop. The problem has been linked to unexpected wear of the main lift assembly, and an uncontrolled drop may cause abrupt patient displacement during surgery. Baxter has received three complaints and reports no patient injuries.

From the FDA notice · Read the official notice ↗ · All Baxter recalls

What to do

  1. Set aside affected units and stop using them for patient procedures.
  2. Check that the model is 1854087 and the serial number is 107971925 (UDI-DI 00887761974067).
  3. The notice does not give a repair or replacement remedy; contact Baxter Healthcare Corporation for next steps.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
1 unit
Illnesses reported
None reported
Manufactured in
1 Baxter Pkwy, Deerfield, Illinois, United States
Classification
Class II
Recall number
Z-0354-2027

In the FDA's words

Description
TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087 There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, the tabletop could not be raised again after the drop occurred. The issue has been associated with unexpected wear of the main lift assembly, also known as the telescopic spindle. An uncontrolled drop of the surgical table may result in an abrupt patient displacement during surgery. Serious or critical adverse health consequences may occur, including traumatic injury, airway compromise, and surgical procedure complications, among others. Baxter has received three complaints related to this issue, with no reported patient injury. Serial numbers: 107971925; UDI-DI number: 00887761974067 Distribution: Worldwide - US Nationwide distribution. Affected quantity: 1 unit
Hazard
There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, the tabletop could not be raised again after the drop occurred. The issue has been associated with unexpected wear of the main lift assembly, also known as the telescopic spindle. An uncontrolled drop of the surgical table may result in an abrupt patient displacement during surgery. Serious or critical adverse health consequences may occur, including traumatic injury, airway compromise, and surgical procedure complications, among others. Baxter has received three complaints related to this issue, with no reported patient injury.

5 products in this recall

Baxter TruSystem surgical tables recalled for unexpected drop risk

Baxter is recalling five surgical table and operating table column models: TruSystem 7500, TruSystem 7000 U, TS7500 MOBIUS, and TruSystem 7500 Hybrid Plus. The main lift may unexpectedly drop to its lowest position during use, and the tabletop could not be raised again after a drop. This has been linked to unexpected wear of the main lift assembly, also called the telescopic spindle. An uncontrolled drop may cause abrupt patient displacement, which could lead to traumatic injury, airway compromise, or surgical complications. Baxter has received three complaints and no patient injuries have been reported.

The agency lists each product separately. Check every one you might have.

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