Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2019 - (Recall #: Z-1040-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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)>

Product Classification:

Class II

Date Initiated: January 15, 2019

Date Posted: March 27, 2019

Recall Number: Z-1040-2019

Event ID: 82187

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.

Status: Terminated

Product Quantity: 56 units

Code Information:

Serial Numbers: MQ0001281001 through MQ0001285004

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated