Device 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)>
Z-1040-2019
Product summary
- Event
- Event 82187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-1040-2019
Official wording
Reason: 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.
Code information: Serial Numbers: MQ0001281001 through MQ0001285004
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.