NeuroLogica Recalls Solid State X-Ray Imagers Due to Foot Injury Risk
NeuroLogica Corporation is recalling 16 solid state x-ray imagers because the retrofit equipment poses a potential foot injury risk during backward transport.
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 (foot injury) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
NeuroLogica Corporation is recalling 16 units of its solid state x-ray imager (flat panel/digital imager), model number GMR40, with serial numbers 00001 through 00016. The recall involves a specific retrofit unit associated with these devices.
The recall was initiated because there is a potential for foot injury from the underside of the detector bin of the retrofit unit while transporting the portable machine in a backwards motion. This hazard is specific to the movement of the device with the retrofit equipment attached.
The affected devices were distributed in the United States, with only one consignee receiving the 16 units. Users of these devices should stop using the affected retrofit equipment and contact NeuroLogica Corporation for further instructions on the recall.
The recalled product
- Product
- Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
- Manufacturer
- NeuroLogica Corporation
- Hazard
- Affected units
- 16
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 (1)
- Model Number GMR40. Serial numbers 00001 through 00016.
Distribution
Distribution scope not specified by the agency.
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