Recall Z-0648-2016— Brainlab AG

Name: FDA recall Z-0648-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-05

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2015-11-05, terminated 2017-08-21. It names one FDA 510(k) clearance: K142108. Product: RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms. Reason: Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0.

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2015-11-05
Terminated: 2017-08-21
Firm location: Feldkirchen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K142108 — RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSISBrainlab AG·cleared 2014-12-16

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

RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

Reason for recall

Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

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