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Luminos Lotus Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

High

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Gore Viabahn VBX Heparin (Gore) – Packaging Defects (2024)

Due to packaging defects, sterility assurance and heparin activity may be compromised.

High

FDAJul 1, 2024Nationwide• W L Gore & Associates, Inc.

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Luminos Lotus Max (Siemens) – Support Arm Lowering Risk (2024)

Gore Viabahn VBX Heparin (Gore) – Packaging Defects (2024)

Everest Bipolar Cutting Forceps (Olympus) – Packaging Breach (2024)

Cobra 3-Plate EMG ET Tube (Neurovision) – Incorrect Tube Size (2024)

Baxter PST 500 U Surgical Table (Baxter) – Potential Device Issue (2024)

IntelliVue Patient Monitor MX400 (Philips) – Software Configuration (2024)

IntelliVue Patient Monitor MX500 (Philips) – Software Configuration (2024)

Medline Semi-Rigid Suction Liners (Medline) – Adverse Events (2024)

Ventana Anti-CD10 Antibody (Ventana) – Staining Inaccuracy (2024)

Arctic Sun Temperature System (Medivance) – Temperature Control Issue (2024)

Link SymphoKnee Sizing Template (Link Bio) – Labeling Error (2024)

Medline Convenience Kits (Medline) – Unspecified Issue (2024)

Capio SLIM Suture Device (Boston Scientific) – Capture Inconsistency (2024)

Medline Convenience Kits (Medline) – Suction Liner Concern (2024)

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

ARTIS Angiography System (Siemens) – Detector Potential Issue (2024)

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

ENT Reservoir Kit (Smiths Medical) – Weld Joint Weakness (2024)

CADD-Solis Battery Pack (Smiths Medical) – Adapter Damage Risk (2024)

DVOT Multi-Pathogen Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)