NA ShroudGuard (REF BF068)Recalls & reported problems
Steris Corporation · The ShroudGuard Surround for 4000 Series Surgical Tables protects the OR table base on four sides with a sturdy, metal structure that prevents accidental damage caused by the pedestal shroud cladding being lowered onto objects placed near or against the pedestal. · Class 1
Data updated Oct 16, 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 00724995203283), received between Jun 18, 2024 and Jun 18, 2024 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT STAFF MEMBERS ARE INJURING THEMSELVES (OBTAINING CUTS) WHEN REMOVING THE SHROUDGUARD COLUMN PROTECTORS FROM THE SURGICAL TABLES FOR CLEANING. IT IS UNKNOWN WHETHER MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Laceration(s)
MAUDE report 19558863 ↗
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- ALLEN 107003Hill-Rom, Inc. · Table, operating-room, electrical1 recall9 reports
- Head-Positioning accessories 1739994Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall1 report
- TS 7500 2067886Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall0 reports
- TS 7500 1717021Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall0 reports
- TS 7500 4091000Baxter Medical Systems GmbH + Co. KG · TABLE, OPERATING-ROOM, ELECTRICAL1 recall0 reports
- ALLEN 107003Hill-Rom, Inc. · Table, operating-room, electrical1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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