Company:Philips Healthcare Inc.
Date of Enforcement Report 5/30/12
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, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
606 units (153 units nationwide and 453 units international)
DISTRIBUTION
Nationwide and Internationally
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