| Date Initiated by Firm | May 07, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on November 01, 2008 |
| Recall Number | Z-1005-04 |
|---|
| Recall Event ID |
29160 |
| 510(K)Number | K013723 |
|---|
| Product Classification |
Transducer, Ultrasonic, Diagnostic - Product Code ITX
|
| Product | Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W. |
|---|
| Code Information |
Serial Numbers: SE15704205, SE16773210, and SE16935305. |
| FEI Number |
1528028
|
Recalling Firm/
Manufacturer |
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
|
| For Additional Information Contact |
330-425-1313 |
|---|
Manufacturer Reason
for Recall | Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04. |
|---|
| Quantity in Commerce | 3 units |
|---|
| Distribution | The devices were shipped to consignees in OH, PA, WI. |
|---|
| 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 = ITX
|
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