Reported Aug 27, 2014 · Terminated
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication…
Philips Healthcare Informatics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare Informatics, Inc. · 4100 E 3rd Ave Ste 101 · Foster City, CA · 94404-4819
Is this the product you have?
- Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
- Lot codes and dates
- IntelliSpace 4.4
- Amount recalled
- 109 units
Why it was recalled
A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
This product could cause temporary or reversible health problems — stop using it.
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