Deerfield Imaging Recalls Intraoperative MRI Systems Due to Venting Line Defect
Deerfield Imaging is recalling specific intraoperative MRI systems because emergency helium venting lines may not have been properly installed.
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 potential safety defect in a medical device (improperly installed emergency venting lines) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Deerfield Imaging is recalling specific models of intraoperative MRI systems, including the Neuro II-SE, Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. These devices are indicated for use as magnetic resonance diagnostic devices (MRDD).
The recall is being issued because the emergency helium venting lines, also known as quench lines, may not have been properly installed. This defect could potentially affect the safety of the equipment during operation.
The recall affects 35 units in the United States and 14 units outside the US. Distribution includes various US states and international locations in China, Canada, Australia, France, Japan, and Germany. Users of these devices should contact Deerfield Imaging for further instructions regarding the installation of the venting lines.
The recalled product
- Product
- Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
- Manufacturer
- Deerfield Imaging
- Category
- Medical Device — MRI Systems
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 (20)
- 70036
- 10076-21
- M00004
- 10073-01
- 23529
- 40481
- M00152
- M00005
- 30445
- M00169
- 060014
- 10043-00
- 30823
- 10004680
- 10050-01
- 40662
- 30935
- 31084
- 31203
- 10002221
Distribution
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