FDA Device recall Z-1325-2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Vari…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Vari… by Varian Medical Systems Oncology Systems, citing under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interloc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1325-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-05-31 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems Oncology Systems |
| Distribution | US |
Product
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
Identifiers
| code_info | CODES: H140001 H140064 H140137 H140721 H140796 H140862 H260947 H270267 H270428 H270539 H270708 H270828 H271017 H14…CODES: H140001 H140064 H140137 H140721 H140796 H140862 H260947 H270267 H270428 H270539 H270708 H270828 H271017 H140002 H140065 H140139 H140723 H140797 H140863 H260949 H270271 H270430 H270540 H270709 H270829 H271018 H140003 H140066 H140141 H140724 H140798 H140865 H260950 H270273 H270431 H270542 H270710 H270833 H271019 H140004 H140067 H140143 H140725 H140799 H140866 H260951 H270277 H270435 H270544 H270711 H270836 H271020 H140005 H140068 H140144 H140726 H140800 H140868 H260952 H270280 H270437 H270547 H270712 H270837 H271021 H140006 H140069 H140145 H140727 H140801 H140869 H260953 H270281 H270438 H270550 H270714 H270838 H271023 H140007 H140070 H140146 H140729 H140803 H140871 H270004 H270282 H270439 H270601 H270716 H270840 H271024 H140008 H140071 H140147 H140731 H140804 H140872 H270006 H270285 H270443 H270602 H270718 H270841 H271026 H140009 H140073 H140148 H140733 H140805 H140873 H270009 H270290 H270445 H270607 H270719 H270842 H271031 H140010 H140074 H140150 H140734 H140806 H140 |
|---|
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-1325-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.