Devices

Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.

Model / Serial
Software versions 3.6.28.x and 4.1.x.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
Product Description
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.
Manufacturer
Philips Healthcare Informatics, Inc.
1 Event
- Recall of Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.

Manufacturer

Philips Healthcare Informatics, Inc.

Manufacturer Address
Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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