| Class 2 Device Recall iSite PACS | |
Date Initiated by Firm | January 04, 2008 |
Date Posted | May 08, 2008 |
Recall Status1 |
Terminated 3 on October 07, 2009 |
Recall Number | Z-1141-2008 |
Recall Event ID |
46414 |
510(K)Number | K042292 |
Product Classification |
patient image management system - Product Code LLZ
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Product | iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404. |
Code Information |
iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and 3.5.65.0 |
Recalling Firm/ Manufacturer |
Philips Healthcare Informatics, Inc. 4100 East Third Avenue Suite 101 Foster City CA 94404
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For Additional Information Contact | Steve Kelly 800-722-7900 Ext. 7479 |
Manufacturer Reason for Recall | Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor. |
FDA Determined Cause 2 | Software design |
Action | Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version. |
Quantity in Commerce | 197 units |
Distribution | Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and 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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510(K) Database | 510(K)s with Product Code = LLZ
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