FDA recall Z-1040-2019

Product

Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

Reason for recall

FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-01-15

Report date

2019-03-27

Termination date

2020-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2019