Company: Philips Healthcare Inc.
Date of Enforcement Report 11/9/11
Class ll:
PRODUCT
MDC PACS – release R2.3 SP1. A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). Recall # Z-0032-2012
REASON
Clinical measurements on true size printouts may be inaccurate.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA,by letter dated August 2011.
Manufacturer: CDP LTD, PETACH TIKVA, Israel. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally
