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)>
- Recall Initiated
- January 15, 2019
- Terminated
- October 8, 2020
- Recall Number
- Z-1040-2019
- Quantity
- 56 units
- Firm Location
- Lexington, MA
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
Lot / Code Info
Serial Numbers: MQ0001281001 through MQ0001285004
Root Cause
Device Design
Action Taken
Fujifilm sent an Urgent Medical Device Correction and Removal letter dated January 16, 2019 to customers. The letter identified the affected product, problem and actions to be taken. Customers were advised to schedule a visit by our Service department to replace the handle assembly. Customers were provided with additional instructions to continue using the affected product safely until the correction was made. For questions call 201-675-8947.
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