Shimadzu Medical Systems Recall 89596
Description: MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Shimadzu Medical Systems Recall 89596 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0869-2022 |
| Event ID | 89596 |
| Event Description | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 |
| Product Type | Devices |
| 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 |
| Quantity | 12 systems |
| Recall 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. |
| Device Classification | 20220413 |
| Device Code Info | Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013 |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220110 |
| Recalling Firm | Shimadzu Medical Systems |
| Initial Notification | Letter |
| Similar To |