Philips IntelliSpace PACS 4.4 image management systems recall: Software Issue
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Why was Philips IntelliSpace PACS 4.4 image management systems 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
IntelliSpace 4.4
- Product
- Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Quantity
- 109 units
- Distribution
- US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Recall date
- August 27, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)