Recall Z-0957-2015— Brainlab AG

Name: FDA recall Z-0957-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-19

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2014-11-19, terminated 2018-03-28. It names 3 FDA 510(k) clearances: K103246, K080888, K053584. 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: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Terminated: 2018-03-28
Firm location: Feldkirchen, Germany

510(k) clearances named in this recall

3 on FDA's record

K103246 — IPLAN RTBrainlab AG·cleared 2011-03-16
K080888 — MODEIFICATION TO IPLAN RT DOSEBrainlab AG·cleared 2008-06-11
K053584 — IPLAN RT DOSEBrainlab AG·cleared 2006-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.