The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)
FDA device recall Z-3158-2024 · posted 2024-09-25 · Open, Classified
Recall details
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Reason for recall
- When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
- Action taken
- Customer and Dealer notification will occur by means of letters alerting customers and dealers to the potential for overexposure to children if the conditions are not checked after the key switch is turned on. The notices also include the plan for the affected mobile x-ray systems. The system will be upgraded, free of charge, with updated software so that the exposure values set by the user are reflected regardless of the state of the key switch.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 130
- Distribution
- US Nationwide and Worldwide
- Date initiated
- 2023-11-23
- Date posted
- 2024-09-25
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FDR AQRO (DR-XD 1000) (K170858) | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-24 |