Data Foundry

Medical device recalls 2013

Software correction applies to customers who use the RT Therapist RTT4 — Class II medical device recall Z-1182-2013

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-05-08, distributed nationwide. Software update to fix multiple safety related issues.

Recall numberZ-1182-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Martinez, CA, United States
Recall initiated2013-04-04
Classified2013-04-26
Reported by FDA2013-05-08
Terminated2013-08-12
DistributedNationwide (US)
Countries outside the USAU, BE, BR, CA, CN, CO, CZ, DE, GB, HR, IE, IN, IT, JP, KR, LB, MX, MY, NO, NZ, PL, RO, SA, SE, TH, TR, ZA
Quantity245 active
Reason classessoftware
Model numbers8162815, 8168754

Product

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

Software update to fix multiple safety related issues.

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-1182-2013. 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.