Date Initiated by Firm | August 10, 2003 |
Date Posted | September 11, 2003 |
Recall Status1 |
Terminated 3 on January 13, 2005 |
Recall Number | Z-1214-03 |
Recall Event ID |
27013 |
510(K)Number | K912470 |
Product Classification |
Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
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Product | Diagnost 94 |
Code Information |
See Diagnost 96 above |
Recalling Firm/ Manufacturer |
Philips Medical Systems Sales & Service Region No. America 22100 Bothell Everett Highway Bothell WA 98041
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For Additional Information Contact | 425-487-7000 |
Manufacturer Reason for Recall | Potential for table to move by itself |
FDA Determined Cause 2 | Other |
Action | The firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade. |
Quantity in Commerce | see Diagnost 96 above |
Distribution | The firm distributed devices to 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 = IZZ
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