Date Initiated by Firm | January 29, 2008 |
Date Posted | August 16, 2008 |
Recall Status1 |
Terminated 3 on September 25, 2008 |
Recall Number | Z-1443-2008 |
Recall Event ID |
46942 |
510(K)Number | K042292 |
Product Classification |
Image Management System - Product Code LLZ
|
Product | Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system. |
Code Information |
Version number 3.6.28.0 |
Recalling Firm/ Manufacturer |
Philips Healthcare Informatics, Inc. 4100 E 3rd Ave Ste 101 Foster City CA 94404-4819
|
For Additional Information Contact | 650-293-2624 |
Manufacturer Reason for Recall | When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool. |
FDA Determined Cause 2 | Software design |
Action | The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem. |
Quantity in Commerce | 3 units |
Distribution | Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany. |
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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510(K) Database | 510(K)s with Product Code = LLZ
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