Company: Philips Medical Systems
Date of Enforcement Report 9/24/2008
Class:ll
PRODUCT
EasyVision RAD – Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms. Part numbers and cooresponding software version in: 9896 050 03232 (SW R4 2V2L2), 9896 050 03233 (SW R4 2V2L3), 9896 050 03234 (SW R4 2V2L4), 9896 050 03235 (SW R4 2V2L5), 9896 050 03236 (SW R4 2V2L5, not delivered to the US), 9896 050 03237 (W R4 2V2L6), and 9896 050 03238 (W R4 2V2L7)., Recall # Z-2053-2008
REASON
Inaccurate measurements when exporting radiography images to Picture Archiving and Communications System (PACS).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America, Co. Phillips, Bothell, WA, by letters on March 14, 2008.
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
401 units
DISTRIBUTION
Nationwide
