Recall Z-2252-2014 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
| Date | Aug 16, 2014 (initiated Jul 24, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail. |
| Quantity | 109 units |
| Distribution | US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111804 | INTELLISPACE PACS 4.X Philips Healthcare Informatics, Inc., Jul 28, 2011 |