ADAC Laboratories Class II

Company: ADAC Laboratories
Date of Enforcement Report: 2/13/02
Class: II

PRODUCT
ADAC brand Pinnacle Radiation Therapy Planning System Radiation Therapy Treatment Software version 5.2g, Recall # Z-0524-02.

REASON
A Software problem that could result in incorrect radiation dosage being applied.

CODE
Model: 9200-0579A.

RECALLING FIRM/MANUFACTURER
ADAC Laboratories, Milpitas, CA, by letters on Sept. 26, 2000. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
373 units.

DISTRIBUTION
Nationwide and internationally.

About the author

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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