IMRIS iMRI operating suite recalled with Baxter TruSystem tables
Baxter is recalling TruSystem surgical tables that are part of the IMRIS iMRI 3T S operating suite, Model 116118-000. The FDA notice does not describe the hazard, and no injuries have been reported. Three units are affected, distributed in the US and China.
From the FDA notice · Read the official notice ↗ · All IMRIS recalls
What to do
- Contact IMRIS or Baxter about the recall, since the notice does not say what remedy is available.
- Check for Baxter TruSystem 7500 surgical tables with serial numbers 108842519, 109343482, or 109370104 (Baxter product code 4091000).
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- IMRIS Operating Suite iMRI 3T S, Model Number 116118-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; Floor System, Skyra Magnet; 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-0443-2027
In the FDA's words
- Description
- IMRIS Operating Suite iMRI 3T S, Model Number 116118-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; Floor System, Skyra Magnet; 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: 108842519, 109343482, 109370104. 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.
- IMRIS Operating Suite iMRX System, Model Number 105828-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; electromechanical operatin…Z-0441-2027 · 1 unit
- IMRIS Operating Suite Neuro III-SV, Model Number: 116189-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical scannerZ-0442-2027 · 2 units
- IMRIS Operating Suite iMRI 3T S, Model Number 116118-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; Floor System, Skyra Magnet;… (this page)Z-0443-2027 · 3 units
- IMRIS Operating Suite InVision 3T Operating Suite, Model Number: 120823-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical s…Z-0444-2027 · 13 units
- IMRIS Operating Suite InVision 1.5T Operating Suite, Model Number: 12111-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical…Z-0445-2027 · 3 units
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