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Moderate riskFDA DeviceClass II

Baxter TruSystem 7000 U surgical table recalled for possible lift drop

The recall covers 16 TruSystem 7000 U surgical tables (Model 1604788). The main lift may unexpectedly drop to its lowest position during use, and the tabletop could not be raised again after a drop. The issue is associated with unexpected wear of the main lift assembly, also called the telescopic spindle. 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 the affected units and contact Baxter Healthcare Corporation and your clinical team about them before any further use.
  2. Check whether each table's serial number or UDI-DI (00887761967526) matches the affected list in the notice.
  3. The notice doesn't say how to get a repair or replacement; contact Baxter Healthcare Corporation.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
16 units
Illnesses reported
None reported
Manufactured in
1 Baxter Pkwy, Deerfield, Illinois, United States
Classification
Class II
Recall number
Z-0352-2027

In the FDA's words

Description
Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788 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: 108517025, 110115554, 110144247, 110188916, 109558596, 110139748, 110166201, 110188918, 109737582, 110139769, 110177678, 110192686, 110115551, 110144245, 110185616, 109889060; UDI-DI number: 00887761967526 Distribution: Worldwide - US Nationwide distribution. Affected quantity: 16 units
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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