Company: Philips Healthcare Inc.
Date of Enforcement Report 5/23/12
Class ll:
PRODUCT
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital. Model #s 712020, 712022, 712082. Recall # Z-1464-2012
REASON
Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated March 30, 2012.
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
606 units
DISTRIBUTION
Nationwide and Internationally
___________________________________