Device Recall iSite PACS

All models, version 3.3

Radiology Devices

2

No

Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3

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

Radiology Devices

2

No

Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.

iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.

Version number 3.6.28.0

Radiology Devices

2

No

Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.

Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.

Version 4.1.17.0

Radiology Devices

2

No

Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.

Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.

Software versions 3.6.28.x and 4.1.x.

Radiology Devices

2

No

Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.

iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. || The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.