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Aurora 2 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Moderate

FDAJul 9, 2024Nationwide• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

McGRATH MAC EMS Laryngoscope (Covidien) – Battery Risk (2024)

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

Very High

FDAJul 9, 2024Nationwide• Covidien

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Aurora 2 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

McGRATH MAC EMS Laryngoscope (Covidien) – Battery Risk (2024)

McGRATH MAC Laryngoscope (Covidien) – Battery Handling Update (2024)

Aurora 3 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

Pyxis QFill Station (CareFusion) – Label Printing Issue (2024)

Diamond Point K-Wire (Smith & Nephew) – Packaging Error (2024)

GM60A X-Ray System (NeuroLogica) – Device Arm Fall Risk (2024)

ENT Cutting Bur (Medtronic Xomed) – Expired Distribution (2024)

Salivary Testosterone ELISA (DRG) – Invalid Controls (2024)

FRT250 Cartridge (Pega Medical) – Incorrect Component (2024)

Sensis Vibe System (Siemens) – Documentation Functionality (2024)

VITROS Folate Reagent Pack (Ortho-Clinical) – Precipitation Issue (2024)

GORE SEAMGUARD Staple Reinforcement (Gore) – Expiration Mislabeling (2024)

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

5 Lead Cable System (Stryker) – Packaging Mixup (2024)

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)

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