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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS

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 Class 2 Device Recall IMRISsee related information
Date Initiated by FirmOctober 16, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0442-2027
Recall Event ID 100216
510(K)NumberK083137 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIMRIS Operating Suite Neuro III-SV, Model Number: 116189-000, IMRIS Product Description ORT400 Table, IMRIS Part Number 119900-000; medical scanner
Code Information IMRIS System UDI/DI 00857534006691, Baxter TruSystem 7500 Surgical table, Baxter Product Code 4091000, Baxter UDI/DI 00887761968639, Serial Numbers: 109047460, 109708813.
FEI Number 3010326005
Recalling Firm/
Manufacturer		 IMRIS Imaging Inc
1230 Chaska Creek Way Ste 100
Chaska MN 55318-2707
For Additional Information Contact
763-203-6300
Manufacturer Reason
for Recall		Operating suite contains TruSystem Surgical Tables which are being recalled by Baxter.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionIMRIS issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/26/2026 via email. The notice explained the issue, hazard involved, and requested the consignee review the enclosed Baxter notice and respond. For questions or concerns, contact the customer support team via the service line at 1-866-475-0525 or e-mail at postmarket@imris.com. A follow-up notice was issued on 11/2/2026 via email which informed the consignee that an IMRIS representative will contact them when the correction becomes available.
Quantity in Commerce2 units
DistributionDistribution to US and China
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
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