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Serious riskFDA DeviceClass II

Baxter TruSystem 7500 surgical table recalled for unexpected drop risk

The main lift on the TruSystem 7500 surgical table may unexpectedly drop from its set position to its lowest position during use, and the tabletop could not be raised again after a drop. Baxter links the issue to unexpected wear of the main lift assembly, also called the telescopic spindle. An uncontrolled drop may cause abrupt patient displacement during surgery; Baxter has received three complaints and reports no patient injury.

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

What to do

  1. Remove affected tables from surgical use and set them aside.
  2. Check the model number 4091000 and UDI-DI 00887761968639, then compare the unit's serial number against the list in the notice.
  3. Contact Baxter Healthcare Corporation about the issue. The notice doesn't say how to get a remedy, so ask Baxter directly.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
TruSystem 7500 surgical table, Model/Catalog Number: 4091000
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
129 units
Illnesses reported
None reported
Manufactured in
1 Baxter Pkwy, Deerfield, Illinois, United States
Classification
Class II
Recall number
Z-0350-2027

In the FDA's words

Description
TruSystem 7500 surgical table, Model/Catalog Number: 4091000 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: 108491706, 108726496, 108758657, 108858029, 108945825, 109083212, 109343910, 109684319, 110016886, 108557062, 108736192, 108773032, 108882327, 108976094, 109174333, 109370104, 109690845, 110016887, 108574826, 108736193, 108773033, 108882328, 108976095, 109174334, 109396256, 109690846, 110072583, 108578755, 108736194, 108842519, 108883564, 108976101, 109174335, 109464647, 109708813, 110084982, 108580717, 108736195, 108842523, 108883565, 109047445, 109174336, 109464648, 109708816, 110086138, 108580718, 108743656, 108842524, 108896687, 109047446, 109228237, 109464649, 109885369, 110144223, 108580720, 108743657, 108842525, 108896688, 109047447, 109228238, 109464650, 109896735, 110144224, 108604827, 108745163, 108842526, 108912913, 109047448, 109249973, 109488031, 109896736, 110144225, 108604828, 108745164, 108842679, 108912914, 109047451, 109249974, 109493243, 109896737, 110158878, 108604832, 108745165, 108842680, 108931731, 109047452, 109249989, 109500155, 109896738, 110158879, 108604833, 108745166, 108849690, 108931732, 109047460, 109301944, 109561673, 109933665, 110175899, 108726492, 108745180, 108849691, 108945772, 109047461, 109301945, 109561674, 109948691, 110175900, 108726493, 108745181, 108849694, 108945823, 109078531, 109301946, 109571317, 110007863, 110163294, 108726495, 108758656, 108849695, 108945824, 109078533, 109343482, 109571318, 110016883, 110163293, 110183861, 110220396, 110220395; UDI-DI number: 00887761968639 Distribution: Worldwide - US Nationwide distribution. Affected quantity: 129 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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