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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

CPT Hip Joint Prosthesis (Zimmer) – Fracture Risk (2024)

Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

High

FDAJul 2, 2024Nationwide• Zimmer, Inc.

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

CPT Hip Joint Prosthesis (Zimmer) – Fracture Risk (2024)

Multitom Rax (Siemens) – Support Arm Lowering Risk (2024)

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

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Micafungin Injection (Zydus) – Cross Contamination (2024)

Decitabine Injection (Sun Pharma) – Microbial Count Issue (2024)

Micafungin Injection (Zydus Pharmaceuticals) – Cross Contamination (2024)

BioPince Biopsy Instrument (Argon Medical) – Packaging Breach (2024)

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

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

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

Fludrocortisone Acetate Tablets (Teva) – Impurity Concerns (2024)

Pravastatin Sodium Tablets (Glenmark) – Dissolution Failure (2024)

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

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

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

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

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