Z-1040-2019 Class II Terminated
FDA device recall Z-1040-2019 was initiated by Fujifilm Medical Systems U.S.A., Inc. on January 15, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 8, 2020). Affected quantity: 56 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- January 15, 2019
- Termination Date
- October 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 units
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)>
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 Pattern
US Nationwide Distribution
Code Information
Serial Numbers: MQ0001281001 through MQ0001285004