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 throughout a clinical environment. The software performs digital image processing, measurement, commu Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 throughout a clinical environment. The software performs digital image processing, measurement, commu
Brand
Philips Healthcare Informatics, Inc.
Lot Codes / Batch Numbers
Versions 4.1.x up to and including 4.1.51.3
Products Sold
Versions 4.1.x up to and including 4.1.51.3
Philips Healthcare Informatics, Inc. is recalling iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3 due to 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 l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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