| Date Initiated by Firm | April 24, 2017 |
|---|
| Create Date | July 26, 2017 |
|---|
| Recall Status1 |
Terminated 3 on January 24, 2018 |
| Recall Number | Z-2769-2017 |
|---|
| Recall Event ID |
77712 |
| 510(K)Number | K142197 K152577 K162065 |
|---|
| Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
| Product | Diagnostics Ultrasound System
Ultrasounds System Sonimage HS1 |
|---|
| Code Information |
UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version) |
| FEI Number |
2241281
|
Recalling Firm/
Manufacturer |
Konica Minolta, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
|
| For Additional Information Contact | Ms. Jan Maniscalco
800-934-1034 Ext. 1427 |
|---|
Manufacturer Reason
for Recall | The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Konica Minolta notified their customers on April 24, 2017. |
|---|
| Quantity in Commerce | 36 units |
|---|
| Distribution | CA, CO, KY, FL, NJ, NY, IA TX, & WA |
|---|
| 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 = IYN
|
|---|
