Recall Z-0269-2014 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems int
| Date | Nov 13, 2013 (initiated Oct 14, 2013) |
| Status | Terminated |
| Reason | Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation. |
| Root cause | Software in the Use Environment |
| Action | Philips sent an Urgent Field Safety Notice dated October 14, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please review the following with all radiology technicians who use lntelliSpace BY CUSTOMER/USER PACS: " Assure you and your colleagues are aware of the problem. " Verify that all images sent for each study are present on the iVault before the images are purged from the modality. o Use the image count from the lower right corner of the thumbnails as seen in Enterprise only. Single images (such as CR, DX and MG) sh |
| Quantity | 71 units |
| Distribution | Worldwide Distribution - USA (nationwide) and country: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.