Siemens MEVATRON series — Class II medical device recall Z-1663-2013

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-07-10, distributed nationwide. The information regarding the FILM Mode calibration may have been considered difficult to interpret when trans

Recall number	`Z-1663-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc, Martinez, CA, United States
Recall initiated	2013-05-29
Classified	2013-07-03
Reported by FDA	2013-07-10
Terminated	2014-01-14
Distributed	Nationwide (US)
Countries outside the US	AR, AT, AU, BE, BG, BR, BS, CA, CL, CN, CO, DE, DZ, EC, EG, ES, FR, GB, GR, HR, HU, ID, IE, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, MX, MY, NL, NO, NP, NZ, PE, PH, PK, PL, PT, RO, SA, SE, SK, SV, TH, TR, TT, TW, VN, ZA
Quantity	1,956 customers

Product

Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1663-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.