Philips Healthcare Informatics, Inc. iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
Brand
Philips Healthcare Informatics, Inc.
Lot Codes / Batch Numbers
iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and 3.5.65.0
Products Sold
iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and 3.5.65.0
Philips Healthcare Informatics, Inc. is recalling iSite PACS image management system; Picture Archiving and Communications System; Radiology software due to Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
Recommended Action
Per FDA guidance
Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.
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