| Date Initiated by Firm | April 25, 2017 |
|---|
| Create Date | February 26, 2018 |
|---|
| Recall Status1 |
Terminated 3 on May 03, 2024 |
| Recall Number | Z-0719-2018 |
|---|
| Recall Event ID |
78973 |
| 510(K)Number | K040228 |
|---|
| Product Classification |
Flowmeter, blood, cardiovascular - Product Code DPW
|
| Product | MEDISTIM VERIQ SYSTEM, MODEL VQ4122
An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. |
|---|
| Code Information |
UDI: 7070554101198 Serial#: 1170 and 1294 |
| FEI Number |
3010790133
|
Recalling Firm/
Manufacturer |
Medistim Asa
Okernveien 94
Oslo
Norway
|
| For Additional Information Contact | Mike Farbelow
763-208-2089 Ext. 852 |
|---|
Manufacturer Reason
for Recall | A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | A letter was sent describing the device, reason for the recall, and risk involved. The firm stated that it would ship a VeriQ replacement system without the affected connector being used. |
|---|
| Quantity in Commerce | 2 |
|---|
| Distribution | Distributed to New York. |
|---|
| 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 = DPW
|
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