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Azurion 7 B12 (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 M20 (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

GE Healthcare Discovery NM 630 (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Moderate
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Brivo NM 615 (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Moderate
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Optima NM/CT 640 (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Moderate
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Varicam Millennium (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Moderate
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

MEDLINE INDUSTRIES, LP Northfield: Medline Iris Scissors, Single-Use, Curved, Standard 4.5 ,...
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Moderate
FDAOct 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Nova Ortho-Med Inc: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH RO...
Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
Moderate
FDAAug 26, 2024Nationwide• Nova Ortho-Med Inc

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands: System Name: 722059 Allura Xper FD20/15 OR Table 722058 A...
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Moderate
FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands: System Name: 722044 INTEGRIS Allura 15-12 (biplane) 72203...
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Moderate
FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands: System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M...
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Moderate
FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands: System Name: 708038 MultiDiagnost Eleva with Flat Detecto...
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Moderate
FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

NeuroLogica Corporation: GM60A. Digital Diagnostic Mobile X-Ray System.
Potential for the anti-fall system of the device arm to fail.
Moderate
FDAJul 8, 2024Nationwide• NeuroLogica Corporation

UNIMAX MEDICAL SYSTEMS INC 8F-2, NO: 1. Tech Medical Services Inc. Detachable Endo Retrieval ...
The tube may fall into the surgical site during the grasping process.
Moderate
FDAJun 25, 2024Nationwide• UNIMAX MEDICAL SYSTEMS INC 8F-2, NO

Medical Depot Inc.: Nitro Glide Knee Walker-offers users recovering from a be...
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Moderate
FDAJun 14, 2024Nationwide• Medical Depot Inc.

NxStage Medical Inc: NxStage PureFlow-B Solution, Premixed Dialysate for Hemod...
The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.
Moderate
FDAMay 14, 2024Nationwide• NxStage Medical Inc

First Source Inc: First Source Vision M. Portable cart and platform that su...
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Moderate
FDAMay 9, 2024Nationwide• First Source Inc

First Source Inc: First Source iQ Flex M. Portable cart and platform that s...
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Moderate
FDAMay 9, 2024Nationwide• First Source Inc

MEDLINE INDUSTRIES, LP Northfield: MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case...
There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
Moderate
FDAApr 30, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield