Class 2 Device Recall MyLab Gamma (Model 7410)

• Date Initiated by Firm: June 11, 2018
• Create Date: October 23, 2018
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-0205-2019
• Recall Event ID: 81285
• 510(K)Number: K142008 K142077 K161359
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: MyLab Gamma, Model 7410
• Code Information: n/a
• FEI Number: 3012981490
• Recalling Firm/ Manufacturer: ESAOTE S.P.A.; Sesto Fiorentino; Via Degli Olmi 11; Sesto Fiorentino Italy
• Manufacturer Reason for Recall: The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.
• FDA Determined Cause: Software design
• Action: On June 11, 2018, the firm notified IH 6-18 probe customers of the product issue through a Field Safety Notice. The letter described the issue and stated that Esaote would provide and install a corrective software update for each affected unit at no cost to the customer. Until the customer receives the corrective software update, customer is requested to refrain from use of the probe IH 618 in BTEI mode or any combined mode including BTEI in Pediatric, Neonatal and Intraoperative clinical applications. For all the other applications, you are requested to monitor the possible temperature rise at the surface of the probe head and immediately stop scanning if the patient notices any discomfort. As a general safety rule, it is recommended to use the probe in default settings, to keep the examination time as short as is necessary to produce a useful diagnostic result and not to hold the probe in a fixed position for any longer than is strictly necessary. Customers are requested to distribute this Field Safety Notice to all appropriate personnel in their organization and forward to all users of the systems, including others to whom they may have transferred the systems, in which case the customer is requested to provide information to Esaote regarding the new owner.
• Quantity in Commerce: 10
• Distribution: Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Switzerland Taiwan Thailand Tunisia Turkey United Kingdom Utd.Arab Emir.
• 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