FDA Device recall Z-2252-2014
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage by Philips Healthcare Informatics, citing 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 updat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2252-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-24 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare Informatics |
| Distribution | n/a |
Product
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
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.
Identifiers
| code_info | IntelliSpace 4.4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2252-2014%22
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