CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
Philips Mdc Pacs R2.X / IntelliSpace Pacs Dcx R3.1 recalled
Philips Medical Systems is recalling Philips Mdc Pacs R2.X / IntelliSpace Pacs Dcx R3.1, distributed in 7 states. The recall was initiated on 2 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1495-2014
- FDA event ID
- 67868
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2014
- FDA classified
- 24 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 2 Apr 2014 | Recall initiated by company | |
| 24 Apr 2014 | Classified by FDA | +22 days |
| 30 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US Distribution including Puerto Rico and the states of CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.
CaliforniaFloridaIllinoisNew JerseyOklahomaPuerto RicoWashington
Questions about this recall
Is Philips Mdc Pacs R2.X / IntelliSpace Pacs Dcx R3.1 recalled?
Yes. Philips Medical Systems recalled Philips Mdc Pacs R2.X / IntelliSpace Pacs Dcx R3.1 on 2 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1495-2014.
Why was it recalled?
Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
Which lots are affected?
Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1
Where was it sold?
Worldwide Distribution - US Distribution including Puerto Rico and the states of CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems
All 81| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | IQon Spectral CT IQon Spectral CT Upgrades recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Spectral CT on Rails recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Model: Incisive CT; Product Code (REF): (1) 728143, (2) recalled | Philips Medical Systems | Lead & Heavy Metals | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |