Company: Philips Healthcare Inc.
Date of Enforcement Report 12/12/12
Class ll:

PRODUCT

Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics.Recall Number Z-0475-2013

REASON
With Digital Diagnost R2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored “R in a circle” appears in the lower left corner. This can be mistaken for a “Right patient side” marker, although this can appear on the left patient side.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA on 10/30/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
623 units

DISTRIBUTION
Nationwide and Internationally

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