Philips MDC PACS R2 — Class II medical device recall Z-1495-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-04-30, distributed in CA, FL, IL, NJ, OK, PR, WA. Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement o
| Recall number | Z-1495-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2016-06-16 |
| Distributed | CA, FL, IL, NJ, OK, PR, WA |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BH, BR, CL, CN, DE, EG, ES, FR, GB, GH, GR, IL, IN, IQ, IT, LT, LV, MT, MX, NP, NZ, PH, PL, PT, PY, RO, RU, SI, SK, TH, TR, ZA |
| Quantity | 373 units |
Product
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others
Reason for recall
Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
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-1495-2014. 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.