FDA Device recall Z-1680-2020
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 by Siemens Medical Solutions Usa, citing potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1680-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-18 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AL, CA, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WI, WV, WY |
Product
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Reason
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Identifiers
| code_info | Serial Numbers 3025, 3049, 3241, 3267, 3305, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3731, 3751, 3832,…Serial Numbers 3025, 3049, 3241, 3267, 3305, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3731, 3751, 3832, 3667, 3924, 3949, 4036, 70-4185, 5153, 3361, 3979, 3657, 3679 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1680-2020%22
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