Recall Z-0948-2009 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data t
| Date | Jan 30, 2009 (initiated Dec 29, 2008) |
| Status | Terminated |
| Reason | Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report. |
| Root cause | Software design |
| Action | Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624. |
| Quantity | 40 units |
| Distribution | International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063267 | ISITE PACS, V 4. X Stentor Inc., A Philips Medical Systems Co., Nov 9, 2006 |