FDA Device recall Z-1679-2020
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC System…
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC System… 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-1679-2020 |
| 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
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 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 3905, 70-4077, 4082, 70-4283, 70-4368, 5177, 3922, 5120, 5170, 5179, 5205, 5226, 5245, 528…Serial Numbers 3905, 70-4077, 4082, 70-4283, 70-4368, 5177, 3922, 5120, 5170, 5179, 5205, 5226, 5245, 5282, 5300, 5343, 5385, 5391, 5506, 5665, 4078, 70-4143, 70-4235, 70-4296, 70-4344, 5154, 5281, 5417, 3755, 3761, 3802, 3801, 3901, 3981, 4072, 70-4174, 70-4354, 70-4378, 5087, 5088, 5096, 5095, 5098, 5118, 5148, 5396, 5157, 5821 |
|---|
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-1679-2020%22
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