Data Foundry

Medical device recalls 2015

iPlan RT is a radiation treatment planning system that is intended… — Class II medical device recall Z-0957-2015

Terminated recall by Brainlab AG, reported 2015-01-21, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple

Recall numberZ-0957-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBrainlab AG, Feldkirchen, Germany
Recall initiated2014-11-19
Classified2015-01-13
Reported by FDA2015-01-21
Terminated2018-03-28
DistributedAL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY
Countries outside the USAR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EC, ES, FI, FR, GB, GR, HK, HN, HU, ID, IE, IL, IN, IT, JP, KR, LB, LT, LV, MX, MY, NL, NO, OM, PA, PL, PT, QA, RO, SA, SE, SG, SI, TH, TN, TR, TW, UA, UY, VE, ZA
Quantity1,412 systems
Reason classessoftware

Product

iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

Reason for recall

iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.

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-0957-2015. 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.