IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Summary
The FDA issued a Class I for IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla M by IMPRIS Imaging Inc. Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemen.
Details
Source
Device Recall
External ID
Z-0164-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Lot/Code Info: IMRIS Part Number(s): 120823-000, UDI/DI 00857534006806
Quantity Affected: N/A
Reason for Recall
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
Chaska, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IMPRIS Imaging Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IMPRIS Imaging Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IMPRIS Imaging Inc have FDA actions?
IMPRIS Imaging Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0164-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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