Date Initiated by Firm | March 08, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on October 29, 2008 |
Recall Number | Z-0786-04 |
Recall Event ID |
27979 |
510(K)Number | K012009 |
Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
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Product | Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. |
Code Information |
Serial Numbers: 2501 to 2554; 3006; 3008 to 3337. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
|
For Additional Information Contact | 440-483-3521 |
Manufacturer Reason for Recall | The CT couch may move downward to its lower limit without command. |
FDA Determined Cause 2 | Other |
Action | The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field. |
Quantity in Commerce | 385 units |
Distribution | The systems were installed at medical facilities located nationwide and worldwide. |
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 = JAK
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