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Moderate riskFDA DeviceClass II

IMRIS operating suite contains recalled Baxter surgical table

Baxter is recalling its TruSystem 7500 surgical table, and an IMRIS Operating Suite iMRX System (model 105828-000) contains one. The notice does not describe the hazard. One unit was affected, and no injuries were reported.

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

What to do

  1. Set aside the affected unit and contact IMRIS Imaging Inc. before using it further.
  2. Check for Baxter TruSystem 7500 surgical table serial number 108578755 (Baxter product code 4091000, UDI/DI 00887761968639) in the IMRIS system (UDI/DI 00857534006691).
  3. The notice doesn't say how to get a repair or replacement; ask IMRIS Imaging Inc. or Baxter.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
IMRIS Operating Suite iMRX System, Model Number 105828-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; electromechanical operating table base
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
1 unit
Illnesses reported
None reported
Manufactured in
1230 Chaska Creek Way Ste 100, Chaska, Minnesota, United States
Classification
Class II
Recall number
Z-0441-2027

In the FDA's words

Description
IMRIS Operating Suite iMRX System, Model Number 105828-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; electromechanical operating table base Operating suite contains TruSystem Surgical Tables which are being recalled by Baxter. IMRIS System UDI/DI 00857534006691, Baxter TruSystem 7500 Surgical table, Baxter Product Code 4091000, Baxter UDI/DI 00887761968639, Serial Number 108578755. Distribution: Distribution to US and China Affected quantity: 1 unit
Hazard
Operating suite contains TruSystem Surgical Tables which are being recalled by Baxter.

5 products in this recall

IMRIS operating suites recalled with Baxter TruSystem surgical tables

IMRIS is recalling five operating suite models that include ORT400 tables, because the operating suites contain Baxter TruSystem surgical tables that Baxter is recalling. The five products are the iMRX System, Neuro III-SV, iMRI 3T S, InVision 3T Operating Suite and InVision 1.5T Operating Suite, with 22 units affected in total. The notice reports no injuries and does not specify a remedy; it was distributed in the US and China.

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

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