OEC 20767 (UDI 00618125152209)Recalls & 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
- 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 00618125152209), received between Jun 7, 2023 and Jun 7, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.
Most reported problems
Device problems
- Device Damaged Prior to Use2
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.
MalfunctionJun 7, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED BY THE CUSTOMER: THERE ARE 2 QTY DEFECTIVE ITEMS. BOTH HAVE THE SAME LOT AND THE SAME EXPIRATION DATE. DETAILS INCLUDING LOT NUMBERS ARE AS FOLLOWS. 1: THE STERILIZATION PACK (COVER) AND THE INNER TUBE COVER ETC. WERE SEALED TOGETHER. 2: THERE WAS A LACK OF SEALING, AND WHEN SEALING, PART OF THE PRODUCT WAS CHEWED AND SEALED. ITEM#E9100AG LOT# 033233 EXPIRATION DATE: 2027-11-12 TOTAL QUANTITY OF DEFECTIVE PRODUCTS:2 QTY THIS FILE WILL ADDRESS THE SECOND REPORTED FAILURE MODE: "THERE WAS A LACK OF SEALING, AND WHEN SEALING, PART OF THE PRODUCT WAS CHEWED AND SEALED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079358 ↗MalfunctionJun 7, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED BY THE CUSTOMER: THERE ARE 2 QTY DEFECTIVE ITEMS. BOTH HAVE THE SAME LOT AND THE SAME EXPIRATION DATE. DETAILS INCLUDING LOT NUMBERS ARE AS FOLLOWS. 1: THE STERILIZATION PACK (COVER) AND THE INNER TUBE COVER ETC. WERE SEALED TOGETHER. 2: THERE WAS A LACK OF SEALING, AND WHEN SEALING, PART OF THE PRODUCT WAS CHEWED AND SEALED. ITEM#E9100AG LOT# 033233 EXPIRATION DATE: 2027-11-12 TOTAL QUANTITY OF DEFECTIVE PRODUCTS:2 QTY THIS FILE WILL ADDRESS THE FIRST REPORTED FAILURE MODE: "THE STERILIZATION PACK (COVER) AND THE INNER TUBE COVER ETC. WERE SEALED TOGETHER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079337 ↗
Other Drape, Surgical, Exempt devices
- Medline DYNJP3102AMedline Industries, Inc. · Drape, surgical, exempt3 recalls2 reports
- Medline DYNJP2498Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls1 report
- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP3103Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8005UGMedline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 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.
How reports and recalls are matched · Editorial policy · Report an error on this page