The Recall Desk
HighFDA (Devices)·Z-1391-2018·Announced 2018-04-25

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.

What this means for you

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
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.