PlainRecalls
FDA Devices Moderate Class II Terminated

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

Reported: April 25, 2018 Initiated: January 12, 2018 #Z-1391-2018

Product Description

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

Reason for Recall

While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

Details

Recalling Firm
NeuroLogica Corporation
Units Affected
16 units
Distribution
US Distribution . Only one consignee was shipped 16 units of the affected device.
Location
Danvers, MA

Frequently Asked Questions

What product was recalled?
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical. Recalled by NeuroLogica Corporation. Units affected: 16 units.
Why was this product recalled?
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1391-2018.