FDA Device recall Z-0438-2014
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination wi…
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination wi… by Siemens Medical Solutions Usa, citing A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments us….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0438-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-23 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA
Reason
A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.
Identifiers
| code_info | Serial Numbers: 5364, 5419, 5640, 5737, 5823, 5830, 5166, 5342, 5416, 5444, 5479, 5485, 5628, 5745, 57…Serial Numbers: 5364, 5419, 5640, 5737, 5823, 5830, 5166, 5342, 5416, 5444, 5479, 5485, 5628, 5745, 5746, 5762, 5763, 5764, 5772, 5781, 5783, 5797, 5815, 5819, 5820, 5822, 5829, 5837, 5839, 5888, 5896, 5911, 5937 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0438-2014%22
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