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U.S. Department of Health and Human Services

Class 2 Device Recall ViewForum Review Station

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  Class 2 Device Recall ViewForum Review Station see related information
Date Initiated by Firm June 08, 2004
Date Posted August 04, 2004
Recall Status1 Terminated 3 on February 09, 2006
Recall Number Z-1308-04
Recall Event ID 29470
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product ViewForum Review Station
Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832.
Code Information 83616, 103380, 102578, 105315, 504608, 104095, 104900, 103620, 505119, 105295, 103540, 105735, 105608, 105493, 101585, 225694, 102492, 504979, 102101, 105290, 105486, 505784, 104079, 504925, 504952, 505815, 505960.
Recalling Firm/
Manufacturer
Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
FDA Determined
Cause 2
Other
Action The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
Quantity in Commerce 27
Distribution Philips Medical Systems North American Company distributes product to medical facilities nationwide.
Total Product Life Cycle TPLC Device Report

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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