660HD-E IMAGE MANAGEMENT SYSTEM 72204668FRecalls & reported problems

Smith & Nephew, Inc. · RFB 660 HD-E IMAGE MANAGEMENT SYSTEM · Class 1

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 00885556630099), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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

Application Program Freezes or Fails to Launch1
No Display/Image1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionApr 3, 2019No Display/Image; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE DEVICE IS FOUND UNSATISFACTORY DUE LOSS OF HDSDI VIDEO SIGNAL. A FINE VERTICAL LINE COVERING THE WHOLE ENTIRE DISPLAY SCREEN AFTER AROUND 10-15 MINUTES OF STILL AND VIDEO CAPTURING., DISABLING THE APPLICATION SCREEN. THERE WAS A COMPLETELY LOSS OF IMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8478094 ↗

Device details

UDI-DI	`00885556630099`
Brand	660HD-E IMAGE MANAGEMENT SYSTEM
Model	72204668F
Company	Smith & Nephew, Inc.
Product code	LMB · Device, digital image storage, radiological
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Endoscopic video imaging system

An assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.

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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 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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