Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/9/2014
Class lI:
PRODUCT
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Recall Number Z-1312-2014
REASON
Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
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RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland OH on 2/11/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1016
DISTRIBUTION
Nationwide and Internationally
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