DOPPLEX DIPP10Recalls & reported problems
Huntleigh Healthcare Limited · DIOP8 PROBE PACK · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05051968036544), received between Feb 1, 2022 and Feb 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Feb 11, 2022Terminated
Faceplate may become detached from the probe body.
Z-0960-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE PROCEDURE THE SINGLE USE PROBE FACEPLATE BECAME DETACHED FROM THE PROBE BODY. HOWEVER IT STAYED CONNECTED VIA THE WIRE ASSEMBLY BEING ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13418038 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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