SUN PLATBRecalls & reported problems
Sizewise Rentals, L.L.C. · 120V Platinum 6000 · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845699003624), received between Jan 22, 2026 and Jan 22, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Electrical /Electronic Property Problem
THE PUMP WAS SENT TO AGILITI FOR REPAIR WITH THE REPORTED ISSUE THAT THE UNIT HAD NO POWER. UPON OPENING THE DEVICE, AN AGILITI TECHNICIAN DISCOVERED INTERNAL BURN DAMAGE THAT CAUSED THE POWER FAILURE. THE BURN MARK WAS LOCATED ON THE POWER BOARD AND MEASURED APPROXIMATELY 1 CM IN DIAMETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146676 ↗MalfunctionJan 22, 2026Electrical /Electronic Property Problem
THE PUMP WAS SENT TO AGILITI FOR REPAIR WITH THE REPORTED ISSUE THAT THE UNIT HAD NO POWER WHEN PLUGGED IN AND WOULD NOT TURN ON. UPON OPENING THE DEVICE, AN AGILITI TECHNICIAN DISCOVERED INTERNAL BURN DAMAGE THAT CAUSED THE POWER FAILURE. THE BURN MARK WAS LOCATED ON THE POWER BOARD AND MEASURED APPROXIMATELY 5 MM IN DIAMETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146428 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.