| Date Initiated by Firm |
January 22, 2021 |
| Create Date |
March 04, 2021 |
| Recall Status1 |
Terminated 3 on November 18, 2022 |
| Recall Number |
Z-1172-2021 |
| Recall Event ID |
87288 |
| 510(K)Number |
K170837
|
| Product Classification |
Display, diagnostic radiology - Product Code PGY
|
| Product |
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY |
| Code Information |
Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388. |
Recalling Firm/
Manufacturer |
Barco N.V.
President Kennedypark 35
Kortrijk Belgium
|
| For Additional Information Contact |
Inge Govaerts
32-56-368052
|
Manufacturer Reason
for Recall |
A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
|
FDA Determined
Cause 2 |
Process change control |
| Action |
On January 22, 2021 the firm notified the importer in the USA, Barco Inc. |
| Quantity in Commerce |
1 unit |
| Distribution |
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 = PGY and Original Applicant = Barco NV
|
