Welch Allyn, Inc. 901109 (REF 5002-KX-B)Recalls & reported problems

Welch Allyn, Inc. · 5002 Mobile stand-on scale with kg only (K), data port (X) and line cord IEC Plug Type-B (B) · 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 00732094227314), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

Material Split, Cut or Torn1

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.

MalfunctionDec 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED POWER SUPPLY HAD EXPOSED WIRING. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696721 ↗

Device details

UDI-DI	`00732094227314`
Brand	Welch Allyn, Inc.
Model	901109
Catalog no.	5002-KX-B
Company	Welch Allyn, Inc.
Product code	FRI · SCALE, STAND-ON, PATIENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 7, 2020

Device type (GMDN): Stand-on floor scale, electronic

An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Other SCALE, STAND-ON, PATIENT devices

Health o meter Professional 498KL
Pelstar, LLC · Scale, Stand-On, Patient
1 recall0 reports
seca 284
seca GmbH & Co. KG · Scale, Stand-On, Patient
1 report
Welch Allyn, Inc. 901110
Welch Allyn, Inc. · SCALE, STAND-ON, PATIENT
1 report
Welch Allyn, Inc. 901109
Welch Allyn, Inc. · SCALE, STAND-ON, PATIENT
1 report

All SCALE, STAND-ON, PATIENT 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 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.

How reports and recalls are matched · Editorial policy · Report an error on this page