Company: Philips Medical Systems, Inc.
Date of Enforcement Report 7/29/2015
Class lI:
PRODUCT
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451.
Recall Number Z-2200-2015
REASON
Philips, Pinnacle Radiation Treatment Planning System version 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA 7/31/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1383
DISTRIBUTION
Nationwide and Internationally
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