Recall Z-3158-2024 ยท IZL System, X-Ray, Mobile
FUJIFILM Healthcare Americas Corporation
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
| Date | Sep 25, 2024 (initiated Nov 23, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 130 |
| Distribution | US Nationwide and Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170858 | FDR AQRO (DR-XD 1000) Fujifilm Medical Systems U.S.A, Inc., Apr 24, 2017 |