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First Aid Alcohol Prep Pads (Rite Aid) – Low Alcohol Levels (2025)
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class IIModerate
FDAJul 7, 2025Nationwide• MEDLINE INDUSTRIES, LP - Northfield
Medline Alcohol Prep Pads (Medline) – Low Alcohol Levels (2025)
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class IIModerate
FDAJul 7, 2025Nationwide• MEDLINE INDUSTRIES, LP - Northfield

ReliOn Alcohol Swabs (Medline) – Low Alcohol Levels (2025)
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class IIModerate
FDAJul 7, 2025Nationwide• MEDLINE INDUSTRIES, LP - Northfield

Hillrom LikoScale (Baxter) – Attachment Hook Risk (2025)
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Moderate
FDAMay 30, 2025Nationwide• Baxter Healthcare Corporation

Hillrom Q-Link 13 Component (Baxter Healthcare) – False Attachment Risk (2025)
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Moderate
FDAMay 30, 2025Nationwide• Baxter Healthcare Corporation

MNA-420 Encoder (Barco) – MAC Address Conflict (2025)
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
Moderate
FDAMay 9, 2025Nationwide• Barco N.V. President Kennedypark 35 Kortrijk Belgium

Atalante X Exoskeleton (Wandercraft) – Balance Loss Risk (2025)
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Moderate
FDAApr 3, 2025NY, PA• WANDERCRAFT SAS

Philips DXR System (Philips) – collimator fall risk (2025)
Potential for collimator to fall as a result of incorrect installation.
Moderate
FDAMar 10, 2025Nationwide• Philips North America Llc

Revolution CT ES System (GE Medical) – Potential System Issue (2025)
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Moderate
FDAFeb 18, 2025Nationwide• GE Medical Systems, LLC

Revolution Apex CT System (GE Medical) – Potential System Issue (2025)
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Moderate
FDAFeb 18, 2025Nationwide• GE Medical Systems, LLC

Revolution CT System (GE Medical) – Potential System Issue (2025)
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Moderate
FDAFeb 18, 2025Nationwide• GE Medical Systems, LLC

Single Use Guide Sheath Kit (Olympus) – radiopaque tip risk (2025)
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Moderate
FDAJan 15, 2025Nationwide• Olympus Corporation of the Americas

Allura Xper FD20/20 (Philips) – Patient Fall Risk (2025)
Possibility of the patient falling from the table related to the mattress used on the patient table.
Moderate
FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura CV20 (Philips) – Patient Fall Risk (2025)
Possibility of the patient falling from the table related to the mattress used on the patient table.
Moderate
FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 5 M12 (Philips) – Patient Fall Risk (2025)
Possibility of the patient falling from the table related to the mattress used on the patient table.
Moderate
FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper FD20/15 (Philips) – Patient Fall Risk (2025)
Possibility of the patient falling from the table related to the mattress used on the patient table.
Moderate
FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 B20 (Philips) – Patient Fall Risk (2025)
Possibility of the patient falling from the table related to the mattress used on the patient table.
Moderate
FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 3 M12 (Philips) – Patient Fall Risk (2025)
Possibility of the patient falling from the table related to the mattress used on the patient table.
Moderate
FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands