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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 361–380 of 1,000 recalls

Class IOngoing

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

NOXBOX LTD

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

September 9, 2025 · DeviceView details →
Class IOngoing

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Draeger, Inc.

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

September 9, 2025 · DeviceView details →
Class IOngoing

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Draeger, Inc.

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

September 9, 2025 · DeviceView details →
Class IOngoing

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

NOXBOX LTD

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

September 9, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

Biograph mMR. Model Number: 10433372.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Verio. Model Number: 10276755.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Lumina (DE). Model Number: 11344916.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Vida Fit. Model Number: 11410481.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Skyra fit. Model Number: 10849580.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Cima.X (DE). Model Number: 11647158.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

Dexcom, Inc.

A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Connectom.X. Model Number: 11371480.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Prisma. Model Number: 10849582.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

BIOGRAPH One (DE). Model Number: 11689172.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
Class IOngoing

MAGNETOM Verio Dot. Model Number: 10684333.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →
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