| Class 2 Device Recall IntelliSpace PACS | |
Date Initiated by Firm | October 14, 2013 |
Date Posted | November 13, 2013 |
Recall Status1 |
Terminated 3 on June 11, 2014 |
Recall Number | Z-0269-2014 |
Recall Event ID |
66560 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | 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 intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. 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. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems. |
Code Information |
All units of these IntelliSpace PACS. |
Recalling Firm/ Manufacturer |
Philips Healthcare Informatics, Inc. 4100 E 3rd Ave Ste 101 Foster City CA 94404-4819
|
For Additional Information Contact | Deana Wiseman 650-293-2300 |
Manufacturer 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. |
FDA Determined Cause 2 | 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) 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. |
Quantity in Commerce | 71 units |
Distribution | Worldwide Distribution - USA (nationwide) and country: Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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