Philips IntelliSpace PACS 4 — Class II medical device recall Z-2252-2014
Terminated recall by Philips Healthcare Informatics, Inc., reported 2014-08-27. A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in
| Recall number | Z-2252-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Informatics, Inc., Foster City, CA, United States |
| Recall initiated | 2014-07-24 |
| Classified | 2014-08-15 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2016-02-11 |
| Countries outside the US | AE, AU, BE, CA, CH, DE, EG, ES, FR, GB, NL, OM, SA |
| Quantity | 109 units |
| Reason classes | software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2252-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.