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)>
FDA Recall Z-1040-2019 · Posted None
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Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2019-01-15
Date Terminated2020-10-08
Product Quantity56 units
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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