Z-2252-2014 Class II Terminated
FDA device recall Z-2252-2014 was initiated by Philips Healthcare Informatics, Inc. on July 24, 2014 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated February 11, 2016). Affected quantity: 109 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- July 24, 2014
- Termination Date
- February 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 units
Product Description
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Reason for Recall
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.
Distribution Pattern
US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Code Information
IntelliSpace 4.4