Philips Medical Systems North America Co. Phillips 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
Site Numbers: 50310, 84026, 103216, 105518, 505284, 505973, 506122, 533261, 536204, 537203, and 557450.
Products Sold
Site Numbers: 50310, 84026, 103216, 105518, 505284, 505973, 506122, 533261, 536204, 537203, and 557450.
Philips Medical Systems North America Co. Phillips is recalling Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is int due to 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 al. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Philips Medical Systems North America Co. sent an URGENT-Field Safety Notice dated January 30, 2009, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised to ascertain the quality of a hard or soft copy explicity before further distribution to make sure that no part of the tissue is covered by image identification information. Philips will issue the Field Change Order (FCO) 83000129 and release a level on EasyVision MM R10.2 L6 and EasyVision MM R11.1 L3 to resolve the issue. Customers could contact Philips Healthcare Call Center at 1-800-722-9377, #2, #3 and Reference FCO 83000129 for any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026