Recall Z-1680-2020 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
| Date | Feb 18, 2020 |
| Status | Terminated |
| Reason | Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| Root cause | Use error |
| Action | A Customer Safety Advisory Notice was sent to all affected consignees on 2/18/2020 via Adobe Mega Sign or USPS certified mail. The notice describes the interlock scenarios, provides user instructions, and warns the user of potential risks. The interlock scenarios are as follows: MONITOR 2: Monitor 2 total dose coincidence. Intent: This interlock is intended to prevent overdose when the primary dose monitory system fails to complete the treatment. TREATMENT TIME: Preset treatment time coincidence with actual treatment time. Intent: This interlock is intended to prevent overdose if preset trea |
| Quantity | 230,001 |
| Distribution | Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pen |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |