C-Armor 5523 (UDI 01618125140151)Recalls & reported problems
Tidi Products, LLC · C-Armor C-arm Equipment Covers Clear Sterile Universal Fit 12 per Case · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 01618125140151), received between Jun 5, 2018 and Aug 22, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination 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.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Device Contamination With Biological Material1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
CUSTOMER DETECTED FOREIGN CONTAMINANT IN STERILE DRAPE WHILE PREPPING THE PATIENT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7807731 ↗MalfunctionJun 5, 2018Device Contamination With Biological Material; Device Contamination With Biological Material
CUSTOMER REPORTED A HAIR WAS FOUND IN THE C-ARM DRAPE WHILE OPENING FOR A CASE. THERE WERE NO SERIOUS INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7571671 ↗
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- Medline DYNJP2412TMedline Industries, Inc. · Drape, surgical2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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