FDA Device recall Z-1677-2020
ARTISTE MV System Model #8139789 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 ARTISTE MV System Model #8139789 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-1677-2020 |
| 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
ARTISTE MV System Model #8139789 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 5350, 5410, 5419, 5481, 5500, 5488, 5532, 5540, 5548, 5572, 5590, 5601, 5630, 5640, 5657,…Serial Numbers 5350, 5410, 5419, 5481, 5500, 5488, 5532, 5540, 5548, 5572, 5590, 5601, 5630, 5640, 5657, 5699, 5707, 5737, 5743, 5748, 5755, 5784, 5823, 5843, 5844, 5851, 5899, 5833, 5894, 5830 |
|---|
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-1677-2020%22
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