Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing,
FDA device recall Z-1495-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- 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
- Action taken
- 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 configure the MRI and CT devices to send regular CT or MR DICOM image objects (not enhanced) to PACS.. This issue does not affect images that are not enhanced image objects. Further questions please call (978) 687-1501.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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, Bosni
- Date initiated
- 2014-04-02
- Date posted
- 2014-04-24
- Date terminated
- 2016-06-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET (K072960) | Cdp, Ltd. | 2007-11-08 |