21

Oct

2009

Cl Il BrainLab Radiotherapy Treatment Planning SW

0

Company:Brainlab AG.
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 – Radiosurgery 3.0 Catalog number 20620 – Radiosurgery 3.5 and Catalog number 20630 – Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals. Recall # Z-2251-2009.

REASON
Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.

RECALLING FIRM/MANUFACTURER
Brainlab AG, Muenchen, Germany, by letter dated August 12, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
216 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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