Recall Weekly
Moderate riskFDA DeviceClass II

IMRIS InVision operating suite recalled for Baxter table issue

The IMRIS InVision 1.5T operating suite (model 12111-000) contains Baxter TruSystem surgical tables that Baxter is recalling. The notice does not describe a specific hazard or any reported injuries. Three units were affected, distributed in the US and China.

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

What to do

  1. Contact IMRIS Imaging or Baxter about the affected units before using them further.
  2. Check the IMRIS system UDI/DI 00857534006691 and Baxter TruSystem 7500 product code 4091000 (UDI/DI 00887761968639).
  3. Match serial numbers 109047461, 109078531, or 109228237 to identify affected Baxter tables.
  4. The notice does not say how to get a remedy; ask IMRIS Imaging or Baxter for next steps.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
IMRIS Operating Suite InVision 1.5T Operating Suite, Model Number: 12111-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical scanner
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
3 units
Illnesses reported
None reported
Manufactured in
1230 Chaska Creek Way Ste 100, Chaska, Minnesota, United States
Classification
Class II
Recall number
Z-0445-2027

In the FDA's words

Description
IMRIS Operating Suite InVision 1.5T Operating Suite, Model Number: 12111-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical scanner 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 Numbers: 109047461, 109078531, 109228237. Distribution: Distribution to US and China Affected quantity: 3 units
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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