Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose

FDA device recall Z-0269-2014 · posted 2013-11-13 · Terminated

Recall details

Recalling firm

Philips Healthcare Informatics, Inc.

Reason for recall

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.

Action taken

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) show no image count, so the user should count those thumbnails without image counts as one. Add all the numbers up to come up with the total number of viewable images, stored to lntelliSpace. " Compare number of images sent from the modality and those sent from other 3rd party source to image count in IntelliSpace PACS. " If the image count on the modality or 3 party source indicates there are more images to the study than are present on the iVault, the study should be resent from the modality and/or 3 party source. " Resending the studies will typically correct the problem but the technician should again verify the image count is correct. If you need any further information or support concerning this issue, please INFORMATION AND contact your Philips representative or contact Care at isitecare@philips.com. Please call (650) 293-2300 for further questions.

Root cause

Software in the Use Environment

Status

Terminated

Product code

LLZ

Quantity affected

71 units

Distribution

Worldwide Distribution - USA (nationwide) and country: Canada.

Date initiated

2013-10-14

Date posted

2013-11-13

Date terminated

2014-06-11

Location

Foster City, CA