IMRIS OR Tables Recalled Due to Magnet Attraction Risk
IMRIS is recalling ORT100 and ORT200 tables used in MRI systems because the foot end may be attracted to the magnet, posing a risk of injury to patients and operators.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Innovative Magnetic Resonance Imaging Systems Inc. (IMRIS) is recalling the ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00) operating room tables. These tables are used in the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems. The recall involves 23 units distributed nationwide, including in Florida, Georgia, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Tennessee, Utah, and Virginia.
The recall was initiated because, if proper procedure is not followed, the foot end of the table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
The source text does not specify specific actions for consumers or healthcare providers beyond the initiation of the recall.
The recalled product
- Product
- IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
- Hazard
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 10002845
- 10002341
- 10003244
- 10002794
- 10003243
- 10003629
- 10003801
- 10002654
- 10002796
- 10002795
- 10002846
- 10002847
- 10003830
- 10003064
- 10005201
- 10003754
- 10004513
Distribution
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