IMRIS Neuro III-SV operating suite recalled with Baxter tables
IMRIS Imaging Inc is recalling two IMRIS Operating Suite Neuro III-SV units because they contain Baxter TruSystem 7500 surgical tables that Baxter is recalling. The notice does not describe the specific hazard. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All IMRIS recalls
What to do
- Set aside any affected IMRIS Operating Suite Neuro III-SV units and do not use them until you have contacted the manufacturer.
- Identify affected units by model 116189-000, IMRIS UDI/DI 00857534006691, and the ORT400 table with part number 119900-000.
- Check for Baxter TruSystem 7500 surgical tables with UDI/DI 00887761968639 and serial numbers 109047460 or 109708813.
- The notice does not give a remedy; contact IMRIS Imaging Inc for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- IMRIS Operating Suite Neuro III-SV, Model Number: 116189-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical scanner
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 2 units
- Illnesses reported
- None reported
- Manufactured in
- 1230 Chaska Creek Way Ste 100, Chaska, Minnesota, United States
- Classification
- Class II
- Recall number
- Z-0442-2027
In the FDA's words
- Description
- IMRIS Operating Suite Neuro III-SV, Model Number: 116189-000, 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: 109047460, 109708813. Distribution: Distribution to US and China Affected quantity: 2 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 scanner (this page)Z-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;…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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