TurboSENSOR™ D560110Recalls & reported problems
Parkell, Inc. · TurboSENSOR™ Ultrasonic Scaler 110 Volt · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810000520527), received between Apr 20, 2026 and Apr 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Temperature Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Temperature Problem1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Temperature Problem
ON MARCH 30, 2026, PARKELL, INC. WAS NOTIFIED OF AN ADVERSE EVENT INVOLVING AN ULTRASONIC SCALER (MANUFACTURED JULY 2025). THE HEALTHCARE PROVIDER REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE, RESULTING IN A PATIENT BURN. ACCORDING TO THE REPORTER, THE PATIENT DID NOT SEEK ADDITIONAL MEDICAL TREATMENT FOLLOWING THE INCIDENT. THE USER NOTED THAT THIS SPECIFIC UNIT (S/N (B)(6)) HAD BEEN RETURNED FOR SERVICE ON TWO PRIOR OCCASIONS FOR REPORTED OVERHEATING. RECORDS INDICATE THAT PREVIOUS SERVICE EVALUATIONS IDENTIFIED THE ROOT CAUSE OF THOSE INSTANCES AS AN INADEQUATE WATER SUPPLY RATHER THAN A MECHANICAL DEFECT. THE DEVICE WAS RETURNED TO THE MANUFACTURER ON APRIL 7, 2026, AND SUBMITTED TO THE ENGINEERING TEAM FOR A FORMAL EVALUATION. COMPREHENSIVE TESTING CONFIRMED THAT THE UNIT IS CURRENTLY FUNCTIONING WITHIN ALL ESTABLISHED ORIGINAL SPECIFICATIONS. THE INVESTIGATION IDENTIFIED NO HARDWARE MALFUNCTIONS OR ELECTRICAL FAULTS THAT WOULD CAUSE THE UNIT TO EXCEED SAFE TEMPERATURE THRESHOLDS UNDER NORMAL OPERATING CONDITIONS. THE ENGINEERING ASSESSMENT CONCLUDED THAT THE REPORTED OVERHEATING WAS LIKELY SECONDARY TO USER TECHNIQUE. SPECIFICALLY, THE INVESTIGATION DETERMINED THAT
Patient problems: Superficial (First Degree) Burn
MAUDE report 24931812 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.