FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: 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 number
- Z-1040-2019
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- 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)>
- Status
- Terminated
- Initiated
- 2019-01-15
- Posted
- not on file
- Terminated
- 2020-10-08
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 56 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: MQ0001281001 through MQ0001285004
- 510(k) numbers
- K080701
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 1000513161
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06