Company: Philips Medical Systems
Date of Enforcement Report 12/22/2010
Class ll:
PRODUCT
Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants. Recall # Z-0412-2011
REASON
Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated January 30, 2009.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
DC, FL, MI, MO, NM, NY, OH, AND TX
