P500 Surface P005787RENT01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761999466), received between Nov 19, 2025 and Feb 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Sparking

  ON 16-JAN-2026, A OTHER HEALTH CARE PROFESSIONAL CONTACTED TECHNICAL SERVICE TO REPORT THAT P500 MRS CONTROL UNIT (PRODUCT CODE P005787RENT02, SERIAL NUMBER (B)(6)), HAD POWER CORD SPARKED. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325544 ↗
• MalfunctionNov 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 26-OCT-2025, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT P500 THERAPY SURFACE (PRODUCT CODE P005787RENT01S, SERIAL NUMBER (B)(6), HAD DAMAGED POWER CORD WITH COPPER WIRES EXPOSED. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596850 ↗