Devices

Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3

Model / Serial
Versions 4.1.x up to and including 4.1.51.3
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
Product Description
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, communication and storage
Manufacturer
Philips Healthcare Informatics, Inc.
1 Event
- Recall of Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3

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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