Shimadzu Medical Systems Recall 89253
Description: Digital Angiography System Bransist safire Generator Model D150GC-40
Shimadzu Medical Systems Recall 89253 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0654-2022 |
| Event ID | 89253 |
| Event Description | Digital Angiography System Bransist safire Generator Model D150GC-40 |
| Product Type | Devices |
| Distribution | U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided. |
| Quantity | 18 |
| Recall Reason | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode. |
| Device Classification | 20220309 |
| Device Code Info | Generator Model: D150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581 |
| Center Classification Date | 20220227 |
| Recall Initiation Date | 20211216 |
| Recalling Firm | Shimadzu Medical Systems |
| Initial Notification | Letter |
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