| Date Initiated by Firm | February 17, 2017 |
|---|
| Create Date | July 10, 2017 |
|---|
| Recall Status1 |
Terminated 3 on October 03, 2018 |
| Recall Number | Z-2706-2017 |
|---|
| Recall Event ID |
76899 |
| 510(K)Number | K063847 |
|---|
| Product Classification |
Gastroscope and accessories, flexible/rigid - Product Code FDS
|
| Product | Ultrasonic Endoscope
Model Number EG-530UT
A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs |
|---|
| Code Information |
1U881A131 1U88A1A145 3U881A005 |
Recalling Firm/
Manufacturer |
Fujifilm Medical Systems U.S.A., Inc.
10 Highpoint Dr
Wayne NJ 07470-7431
|
| For Additional Information Contact | Ms. Sarah Contreras
973-709-2202 |
|---|
Manufacturer Reason
for Recall | Fujifilm is recalling multiple endoscopes after a retrospective review. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Fujifilm sent an Urgent - Medical Device Removal letter dated February 17, 2017. Customers are provided information regarding the recall and asked to complete the attached form and return to Fujifilm. Questions can be directed to sales representative. For further questions, please call (973) 709-2202. |
|---|
| Quantity in Commerce | 4 units |
|---|
| Distribution | US Distribution to : AL, HI and MO |
|---|
| 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 = FDS
|
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