Sun Nuclear IC Profiler-MR Recalled for Pinch Hazard
Sun Nuclear Corporation is recalling six IC Profiler-MR Model 1123 units due to a potential pinch hazard to users performing quality assurance in MRI environments.
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 (pinch hazard) where injury has not yet been reported, which aligns with the criteria for a High severity score.
Plain-English summary
Sun Nuclear Corporation is recalling six units of the IC Profiler-MR Model 1123. This device is a radiologic quality assurance instrument intended for medical purposes to measure physical characteristics associated with other radiologic devices.
The recall is being issued because the device presents a potential pinch hazard to users performing machine quality assurance in an MRI environment. The affected units were distributed in the states of California, Colorado, and Ohio. Specific serial numbers for the recalled units are 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003.
Users of these devices should stop using them and contact Sun Nuclear Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
- Manufacturer
- Sun Nuclear Corporation
- Hazard
- Affected units
- 6
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 (9)
- Serial #'s: 92327001
- 92327002
- 92327003
- 84118005
- 84118006
- 84118004
- 84118001
- 84118002
- and 84118003
Distribution
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