OEC 20768Recalls & reported problems

Tidi Products, LLC · OEC C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00618125152216), received between Jun 5, 2026 and Jun 5, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 5, 2026Break
CUSTOMER REPORTED AN INCREASE IN FREQUENCY OF DEFECTS IN E9100AH. THE ISSUE INVOLVES A COMPONENT THAT IS USED TO SECURE THE BLUE SHEET TO THE PLASTIC ARM-FIXING BRACKET. THIS COMPONENT HAS BEEN DETACHING, AND THE OCCURRENCE OF THIS ISSUE HAS INCREASED OVER THE PAST TWO MONTHS. THE AFFECTED LOT NUMBERS ARE AS FOLLOWS: LOT : 68540560 LOT : 68540559 LOT : 68233553 LOT : 039373.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25413128 ↗

Device details

UDI-DI	`00618125152216`
Brand	OEC
Model	20768
Company	Tidi Products, LLC
Product code	PUI · Drape, Surgical, Exempt
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Medical equipment/instrument drape, single-use

A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

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All Drape, Surgical, Exempt devices →

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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