Recall Z-0867-2022 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Shimadzu Medical Systems
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
| Date | Jan 10, 2022 |
| Status | Open, Classified |
| Reason | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation. |
| Root cause | Software design |
| Action | On or about 1/7/2022, the firm sent an "Urgent: Voluntary Medical Device Recall Notice" to customers informing them that there is a potential issue with the adjustment procedure of the generator on the SonialVision (G$ and safire) Systems and FluoroSpeed X1 Systems. As a result of the Recalling Firm's investigation and testing it was proven that there is a problem with the adjustment procedure documented for the calibration of the system xray generator. This problem occurs during the calibration of the fluoroscopic mode which could cause x-ray radiation dose rate to exceed regulation and/or s |
| Quantity | 25 systems |
| Distribution | U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, and WV. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191877 | FLUOROspeed Shimadzu Corporation, Aug 5, 2019 |