| Date Initiated by Firm | May 13, 2014 |
|---|
| Date Posted | August 10, 2014 |
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| 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 |
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| Action | Only one customer was affected no customer letter was issued field correction was conducted.. |
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| Quantity in Commerce | 1 |
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| Distribution | US in the state of WV |
|---|
| 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.
|
| 510(K) Database | 510(K)s with Product Code = IZL
|
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