Data Foundry

Medical device recalls 2014

PRIMUS — Class II medical device recall Z-0787-2014

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-01-29, distributed nationwide. Update to correct the possibility for patients or operators to have their fingers trapped or pinched between t

Recall numberZ-0787-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Martinez, CA, United States
Recall initiated2013-12-05
Classified2014-01-17
Reported by FDA2014-01-29
Terminated2015-01-30
DistributedNationwide (US)
Countries outside the USAR, BG, BR, CA, CH, CN, DE, DZ, EG, ES, FR, HR, HU, ID, IN, IR, IT, JP, LB, LK, PK, PL, PT, SK, TR, TT, UA, VN, ZA
Quantity305 active
Model numbers07346534

Product

PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, 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

Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau

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-0787-2014. 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.