FDA recall Z-1391-2018

Product

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.

Distribution

US Distribution . Only one consignee was shipped 16 units of the affected device.

Key facts

Status

Terminated

Initiation date

2018-01-12

Report date

2018-04-25

Termination date

2018-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2018