Date Initiated by Firm | May 13, 2014 |
Date Posted | August 10, 2014 |
Recall Status1 |
Terminated 3 on August 13, 2014 |
Recall Number | Z-2176-2014 |
Recall Event ID |
68798 |
510(K)Number | K103597 |
Product Classification |
System, x-ray, mobile - Product Code IZL
|
Product | Agfa Digital Radiography X-Ray System DX-D 100
Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses. |
Code Information |
Serial Number A5410000042 |
Recalling Firm/ Manufacturer |
AGFA Healthcare Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact | Debbie Huff 864-421-1754 |
Manufacturer Reason for Recall | Unit was mislabeled with a factory label showing 32 KW output power. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Only one customer was affected no customer letter was issued field correction was conducted.. |
Quantity in Commerce | 1 |
Distribution | US in the state of WV |
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 = IZL
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