BZGClass II

Spirometer, Diagnostic

Anesthesiology · 21 CFR 868.1840

MDR events31All time

Recalls1All time

Registered firms184Currently listed

510(k) clearances228All time

Recent MDR events

31 adverse event reports on file

LOCAL ANESTHESIA CUSTOM PACK (EPIDURAL)May 25, 2026
MalfunctionIcu Medical, Inc.3012307300-2026-05326
WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITEMay 21, 2026
MalfunctionBaxter Healthcare Corporation1316463-2026-00303
CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWAREMay 15, 2026
MalfunctionWelch Allyn Inc1316463-2026-00038
SMARTCARE CONNECT PREMIUM PLUS - TIER DApr 1, 2026
MalfunctionWelch Allyn Inc1316463-2026-00018
SPIROBANK IIFeb 14, 2025
MalfunctionMir - Medical International Research Spa21383968
POWERCUBE ERGONov 13, 2024
MalfunctionGanshorn Medizin Electronic GmbhMW5162544
FVC (FORCED VITAL CAPACITY) TESTApr 30, 2024
InjuryUnknownMW5154455
COMPAS2Mar 20, 2024
MalfunctionMorgan Scientific, Inc.18939581
SPIROPERFECTAug 11, 2023
MalfunctionMedikro OyMW5123318
VMAXMay 19, 2023
MalfunctionVyaire Medical2021710-2023-17704

Event type breakdown

Malfunction22

Injury6

Unspecified2

Other1

Most-reported manufacturers

Vyaire Medical7 Medikro Oy2 Welch Allyn Inc2 Baxter Healthcare Corporation1 Carefusion, Inc1 Ert1 Ganshorn Medizin Electronic Gmbh1 Gemtech Corp.1

Recalls

1 recall events for this product code

Baxter Healthcare Corporation
Open, ClassifiedNov 7, 2024
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Z-0324-2025 · View FDA record ↗

Registered firms

184 firms currently registered for this product code

510(k) clearances

228 clearances for this product code