Recall Z-1040-2019 ยท IZL System, X-Ray, Mobile
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)>
| Date | Jan 15, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp., May 14, 2008 |