Invivo Breast MRI Auxiliary Table Recalled Due to Missing Diode
Invivo Corporation is recalling three breast MRI auxiliary tables because a missing diode may cause the coil to overheat.
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 (potential overheating) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Invivo Corporation is recalling three units of the Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. The recall is due to a manufacturing error where a diode was inadvertently not assembled into the system.
The missing component may result in coil overheating. The affected units are identified by Model # 9896-032-14382 and Serial # 13, 14, and 15. These units were distributed in Wisconsin.
The source text does not specify specific consumer actions or report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
- Manufacturer
- Invivo Corporation
- Category
- Medical Device — MRI Coil
- Hazard
- Affected units
- 3
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 (4)
- Model #: 9896-032-14382
- Serial #: 13 (production order 301128446)
- 14 (production order 301153586)
- and 15 (production order 301153587).
Distribution
Distributed in 1 state:
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