Company: Philips Medical Systems North America Co.
Date of Enforcement Report 9/22//2010
Class ll:
PRODUCT
DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. Recall # Z-2422-2010
REASON
When using DICOM print functionality, the printed images may contain data for the wrong patient.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated March 10, 2008.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr. Hamburg, Germany. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
119 units
DISTRIBUTION
Nationwide
