Spirometer, Monitoring (W/Wo Alarm)
FDA adverse event reports and recall history for spirometer, monitoring (w/wo alarm) (product code BZK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 136
- Deaths
- 2
- Injuries
- 4
- Malfunctions
- 123
Reports per year
Source: FDA adverse event reports by year received, 1993–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-09-30TerminatedManufacturing material removal
PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
Pressure lines maybe occluded and display incorrect tidal volumes.
- 2011-09-30TerminatedManufacturing material removal
FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
Pressure lines maybe occluded and display incorrect tidal volumes.
- TerminatedDevice Design
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Monitor spirometer, monitoring (w/wo alarm) automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.