Date Initiated by Firm | February 13, 2002 |
Date Posted | September 12, 2003 |
Recall Status1 |
Terminated 3 on April 11, 2005 |
Recall Number | Z-1223-03 |
Recall Event ID |
26547 |
510(K)Number | K983447 |
Product Classification |
System, Image Processing, Radiological - Product Code LLZ
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Product | Easy Access PACS System with software Release 5, 6.2, or 7.2 |
Code Information |
To be provided |
Recalling Firm/ Manufacturer |
Philips Medical Systems 22100 Bothell Everett Highway Bothell WA 98041
|
For Additional Information Contact | 425-487-7000 |
Manufacturer Reason for Recall | Potential display of an incorrect body part description on patient images. |
FDA Determined Cause 2 | Other |
Action | On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion. |
Quantity in Commerce | 46 units |
Distribution | The firm distributed units to 46 hospitals and medical centers located throughout the U.S. |
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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