FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Fujifilm FDR Go Plus mobile X-ray system
- Recall number
- Z-2441-2019
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Fujifilm FDR Go Plus mobile X-ray system
- Status
- Terminated
- Initiated
- 2019-07-19
- Posted
- not on file
- Terminated
- 2020-08-28
- Reason
- The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
- Root cause
- Software design
- Action
- Fuji Film issued notifications via FedEx standard overnight mail on July 19, 2019 advising of the problem, health risk and action to take: During this field action, you can continue to use your current FDR Go PLUS by following these additional instructions:1. Set the monitor sleep mode to Off. Complete the Field Action Verification Form, and upon receipt FUJIFILM service personnel will contact you to schedule a visit to correct your device.FUJIFILM will correct your affected device(s) by applying a registry file to your current software version, at no cost to you.. Question contact: Field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email mailto:jeffrey.wan@fujifilm.com
- Quantity
- 174 units
- Distribution
- Nationwide
- Lot, serial or model codes
- All serial numbers
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28