Company: Computerized Medical Systems Inc.
Date of Enforcement Report 8/24/11
Class ll:
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2593-2011
REASON
XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated. The Setup Reference Definition index in XiO displays only the Patient Scan position.
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 27, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14000 units
DISTRIBUTION
Nationwide and Internationally
