Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MyLab Ultrasound System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MyLab Ultrasound System see related information
Date Initiated by Firm January 03, 2018
Create Date March 20, 2018
Recall Status1 Terminated 3 on May 30, 2019
Recall Number Z-1138-2018
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; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
Code Information Software versions 12.10 - 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 5
Distribution US distribution in the states: AZ, FL, OK, PA, and TX.
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 and Original Applicant = ESAOTE S.P.A
510(K)s with Product Code = IYN and Original Applicant = ESAOTE S.P.A.
-
-