Date Initiated by Firm |
January 03, 2018 |
Create Date |
March 20, 2018 |
Recall Status1 |
Terminated 3 on May 30, 2019 |
Recall Number |
Z-1137-2018 |
Recall Event ID |
79547 |
510(K)Number |
K163082 K081386
|
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
Product |
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 |
Code Information |
Software versions 4.0 - 13.60 |
Recalling Firm/ Manufacturer |
ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy
|
For Additional Information Contact |
Allison Scott (Consultant) 317-272-5419
|
Manufacturer Reason for Recall |
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
|
FDA Determined Cause 2 |
Software design |
Action |
The January 3, 2018, notification letter requests the consignee complete and return a recall response form. The letter states that Esaote customer service will contact the consignee about the software update. In the meantime, it is recommended that the consignee does not use the PA023E probe in Pulsed Wave (PW) Doppler mode and that they refrain from using the system in Elaxto mode where the patient is unconscious or sedated. The consignee is asked to check the temperature of the probe before use. |
Quantity in Commerce |
1 |
Distribution |
US distribution in the states: AZ, FL, OK, PA, and TX. |
Total Product Life Cycle |
TPLC Device Report
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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 and Original Applicant = ESAOTE S.P.A 510(K)s with Product Code = IYN and Original Applicant = ESAOTE S.P.A.
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