Recall Z-0412-2011 ยท LLZ System, Image Processing, Radiological
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 demonst
| Date | Nov 18, 2010 (initiated Jan 30, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | 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 conta |
| Quantity | 11 units in US |
| Distribution | Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX |
| FDA record | Open on fda.gov |