DeRoyal M60-SF505Recalls & reported problems

Deroyal Industries, Inc. · Multi-Angle Positioning Kit · Class 1

Data updated Oct 18, 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 00749756390248), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Unintended Movement1

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.

MalfunctionFeb 20, 2025Unintended Movement; Unintended Movement
A USER FACILITY REPORTED, "WE HAD A PATIENT THAT SLID ON THE BED TODAY USING THE BLACK PAD. HER LEGS WERE STRAIGHT, AND SHE WAS A VERY TINY GIRL. IS THERE A WEIGHT LIMIT AS TO MAYBE SHE WAS TOO SMALL AND THAT'S WHY SHE SLID"
Patient problems: Insufficient Information
MAUDE report 21424550 ↗

Device details

UDI-DI	`00749756390248`
Brand	DeRoyal
Model	M60-SF505
Company	Deroyal Industries, Inc.
Product code	CCX · SUPPORT, PATIENT POSITION
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 20, 2023

Device type (GMDN): Freestanding patient positioner, single-use

A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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