MyLabAlpha 101740000Recalls & reported problems
Esaote SPA · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08056304450012), received between Jul 14, 2020 and Jul 17, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Electrical /Electronic Property Problem4
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
CUSTOMER REPORTED THAT THEY SAW SMOKE COMING OUT OF THE DC ADAPTER. THEY IMMEDIATELY UNPLUGGED THE CORD AND DID NOT USE IT AGAIN. THERE WERE NO INJURIES OR OTHER DAMAGE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10290229 ↗MalfunctionJul 14, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
CUSTOMER REPORTED THAT THEY SAW SMOKE COMING OUT OF THE DC ADAPTER. THEY IMMEDIATELY UNPLUGGED THE CORD AND DID NOT USE IT AGAIN. THERE WERE NO INJURIES OR OTHER DAMAGE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10274266 ↗MalfunctionJul 14, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
WHILE ULTRASOUND SYSTEM WAS PLUGGED INTO THE WALL SOCKET AND DURING USE, SMOKE APPEARED TO COME FROM THE AC POWER BRICK FOR THE SYSTEM (IT PLUGS INTO THE MACHINE AND THE WALL POWER SOCKET).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10274265 ↗MalfunctionJul 14, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
CUSTOMER REPORTED THAT THEY SAW SMOKE COMING OUT OF THE DC ADAPTER. THEY IMMEDIATELY UNPLUGGED THE CORD AND DID NOT USE IT AGAIN. THERE WERE NO INJURIES OR OTHER DAMAGE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10274264 ↗
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- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.