Company: Varian Medical Systems, Inc.
Date of Enforcement Report 6/22/2011
Class ll:
PRODUCT
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions. Recall # Z-2176-2011
REASON
The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated March 3, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
599 units
DISTRIBUTION
Nationwide and Internationally
