HITACHI L44LARecalls & reported problems
Hitachi, Ltd. · Probe · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04562122958431), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
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.
InjuryJul 15, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON JUNE 16, 2025, FUJIFILM CORPORATION RECEIVED A CUSTOMER COMPLAINT. DURING LAPAROSCOPIC SURGERY AT A MEDICAL FACILITY IN JAPAN, PART OF THE FILLER MATERIAL FROM THE L44LA PROBE DETACHED AND ENTERED THE PATIENT'S BODY. THE PHYSICIAN NOTICED THE DETACHED FILLER MATERIAL AT THE SCENE AND REMOVED IT. THERE WERE NO ADVERSE HEALTH EFFECTS FROM THE FILLER, BUT THE PROCEDURE TOOK LONGER THAN EXPECTED BECAUSE SOME OF THE FILLER HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22504701 ↗
Other System, Imaging, Pulsed Echo, Ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- Site~Rite 8 Ultrasound System 9770600Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic629 reports
- Site-Rite 9770501Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic546 reports
- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page