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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

2 recalls

1 recall

GE HealthCare Revolution CT Scanners

GE HealthCare computed tomography systems have a potential security vulnerability that could impact AW Server via Edison Health Link.

Moderate riskFDASoftware defect
GE HealthCare Revolution CT Scanners

1 recall

2 recalls

North American Rescue AIDBAG First Aid Kits

AIDBAGs first aid kits contain a blood glucose system that can display an error code, leading to operator confusion and delayed treatment.

High riskFDASoftware defect
North American Rescue AIDBAG First Aid Kits

Beta Bionics iLet Bionic Pancreas

The iLet Bionic Pancreas software may delay CGM readings, leading to severe hyperglycemia or hypoglycemia.

Moderate riskFDASoftware defect
Beta Bionics iLet Bionic Pancreas

1 recall

1 recall

1 recall

1 recall

2 recalls

Gentuity HF-OCT Imaging System

The Gentuity HF-OCT Imaging System may show repeated frames during pullback, affecting length measurements.

Moderate riskFDASoftware defect
Gentuity HF-OCT Imaging System

Philips Spectral CT on Rails

Philips Spectral CT on Rails has software issues that could cause the gantry to remain at the current scan position.

Moderate riskFDASoftware defect
Philips Spectral CT on Rails

1 recall

eTRAX Needle Sensor and System Starter Kit

The eTRAX Needle System Starter Kit has an error in inspection and programming, potentially causing incorrect needle tip position on the interface.

Moderate riskFDASoftware defect
eTRAX Needle Sensor and System Starter Kit

1 recall

RefleXion X1 Radiotherapy System

The RefleXion X1 Radiotherapy System has a software defect that can deliver the treatment dose to an incorrect location.

Moderate riskFDASoftware defect
RefleXion X1 Radiotherapy System

1 recall

Medtronic MiniMed 780G Insulin Pumps

The MiniMed 780G insulin pump with software versions 6.60 and 6.61 has software defects that could cause hypoglycemia or hyperglycemia.

Moderate riskFDASoftware defect
Medical devices

1 recall

Welch Allyn Spot Vision Screener VS100

The Welch Allyn Spot Vision Screener VS100 may have a flickering display that can cause seizures in susceptible people.

Moderate riskFDASoftware defect
Welch Allyn Spot Vision Screener VS100

1 recall

Centricity Universal Viewer Software

Centricity Universal Viewer Software has a cybersecurity vulnerability that may expose user login credentials.

Moderate riskFDASoftware defect
Medical devices

1 recall

1 recall

1 recall

Hitachi Proton Beam Therapy

The Hitachi Proton Beam Therapy System has a software anomaly in its patient positioning system that may cause positional discrepancy.

Moderate riskFDASoftware defect
Hitachi Proton Beam Therapy

1 recall

Olympus High Flow Insufflation Unit

The Olympus High Flow Insufflation Unit has a software issue that may lead to overpressure events.

High riskFDASoftware defect
Olympus High Flow Insufflation Unit

1 recall