Class IIOngoingZ-3220-2026
Midmark Corporation recalls Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark CorporationOHSep 30, 2026
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–11 of 11 recalls
Class IIOngoingZ-3219-2026
Midmark Corporation recalls Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark CorporationOHSep 30, 2026
Class IIOngoingZ-3218-2026
Midmark Corporation recalls Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark CorporationOHSep 30, 2026
Class IIOngoingZ-3217-2026
Midmark Corporation recalls Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark CorporationOHSep 30, 2026
Class IIOngoingZ-3039-2026
GE Medical Systems Information Technologies Inc recalls FRU (Field replaceable unit)
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-3038-2026
GE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.0.5
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-3037-2026
GE Medical Systems Information Technologies Inc recalls PORTRAIT COMPUTE AND CORE SERVICES V1.2
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-3036-2026
GE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.1
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
GE Medical Systems Inf…WISep 2, 2026
Class IIOngoingZ-2878-2026
GE Medical Systems Information Technologies Inc recalls GE Healthcare Portrait Core Services SW V 1.2.0
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI…
GE Medical Systems Inf…WIAug 12, 2026
Class IIOngoingZ-1557-2026
Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Nu…
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Covidien LLCCOMar 18, 2026
Class IIOngoingZ-1144-2026
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan DiagnosticsCAJan 28, 2026