CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
MyLab Ultrasound System recalled by Esaote S.p.a
Esaote is recalling MyLab Ultrasound System, distributed in Arizona, Florida, Oklahoma, Pennsylvania, Texas. The recall was initiated on 3 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1137-2018
- FDA event ID
- 79547
- Recalling firm
- Esaote, Sesto Fiorentino, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2018
- FDA classified
- 20 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 3 Jan 2018 | Recall initiated by company | |
| 20 Mar 2018 | Classified by FDA | +76 days |
| 28 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Product as listed by the FDA
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Where it was distributed
US distribution in the states: AZ, FL, OK, PA, and TX.
Questions about this recall
Why was it recalled?
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Which lots are affected?
Software versions 4.0 - 13.60
Where was it sold?
US distribution in the states: AZ, FL, OK, PA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 79547This product is part of a recall event; the main page for the event is MyLab Ultrasound System recalled by Esaote S.p.a.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MyLab Ultrasound System recalled by Esaote S.p.a | Esaote | Other | 5 states |
More recalls from Esaote
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Endocavity ultrasonic probe recalled by Esaote S.p.a | Esaote | Packaging Defects | Nationwide |
| Device | CLASS II | AC/DC Power Supply recalled by Esaote S.p.a | Esaote | Other | Nationwide |
| Device | CLASS II | AC/DC Power Supply recalled by Esaote S.p.a | Esaote | Other | Nationwide |
| Device | CLASS II | MyLab Seven recalled by Esaote S.p.a | Esaote | Device Malfunction | Nationwide |
| Device | CLASS II | MyLab Alpha recalled by Esaote S.p.a | Esaote | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |