Sophysa PSO-4000Recalls & reported problems
Sophysa · PRESSIO 2 ICP MONITOR · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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 03760124132076), received between Jun 10, 2025 and Jun 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unexpected Shutdown” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 17, 2025Open, Classified
Customer complaints of Pressio monitor rebooting.
Z-1029-2026 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Unexpected Shutdown1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2025Unexpected Shutdown; Unexpected Shutdown
PRESSIO2 MONITOR WILL NOT SHUT DOWN. IT RESTART EVERY TIME THEY TRY TO SHUNT DOWN. THEY HAVE TRIED EMPTY THE BATTERIE AND RELOAD IT AGAIN, BUT THE SAME PROBLEM OCCUR. THE MONITOR IS LESS THAN 2 YEARS OLD.
Patient problems: Insufficient Information
MAUDE report 22173713 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.