Recall Z-0205-2019— ESAOTE S.P.A.
Class II · Terminated
Class II FDA medical device recall by ESAOTE S.P.A., initiated 2018-06-11, terminated 2020-05-12. It names 3 FDA 510(k) clearances: K161359, K142008, K142077. Product: MyLab Gamma, Model 7410. Reason: 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..
- Recalling firm
- ESAOTE S.P.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-11
- Terminated
- 2020-05-12
- Firm location
- Sesto Fiorentino, N/A, Italy
510(k) clearances named in this recall
3 on FDA's record- K161359 — 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
- K142008 — MYLABSEVEN, MYLABALPHA
- K142077 — MYLABGAMMA
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MyLab Gamma, Model 7410
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.