Company: Philips Healthcare Inc.
Date of Enforcement Report 10/26/11
Class ll:

PRODUCT
PCR Eleva Radiological Image Processing System with software R.1.2. A computed radiography image processing system. Recall # Z-3205-2011

REASON
The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated June 10, 2011.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
197 units

DISTRIBUTION
Nationwide and Internationally