Recall Z-1495-2014 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems, Inc.
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
| Date | Apr 24, 2014 (initiated Apr 2, 2014) |
| Status | Terminated |
| Reason | Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations |
| Root cause | Software design |
| Action | Philips Healthcare sent a Urgent Medical Device Correction Notification/Field Safety Notice dated March 2014, to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace the software free of charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Until you receive a software upgrade from Philips, the user must configur |
| Quantity | 373 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072960 | CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET Cdp, Ltd., Nov 8, 2007 |