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OmniTom X-ray CT System (NeuroLogica) – Device Mobility Risks (2023)

1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

Moderate

FDAJun 6, 2023Nationwide• NeuroLogica Corporation

Pierce Ladder and Platform (PIERCE) – Structural Integrity (2023)

Pierce Manufacturing (Pierce) is recalling certain 2016-2022 Ascendant 107' Aerials and 110' Platforms mounted on single rear axle Enforcer chassis. The galvanized stabilizer beams may develop cracks.

Moderate

NHTSAJun 6, 2023Nationwide• PIERCE

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OmniTom X-ray CT System (NeuroLogica) – Device Mobility Risks (2023)

Pierce Ladder and Platform (PIERCE) – Structural Integrity (2023)

Vios Bedside Monitor (Murata Vios) – Pulse Oximeter Sensor Failure (2023)

NanoZoomer S360MD Slide Scanner (Hamamatsu) – Incorrect Barcode Identification (2023)

Catalyft LS Interbody System (Medtronic) – Geometry Specification Issue (2023)

L'Air Trillium Heritage Camper (L'AIR CAMPER) – Appliance Safety (2023)

Mitsubishi Outlander (MITSUBISHI) – Display Software Error (2023)

Cios Select X-ray System (Siemens) – Plexiglass Cover Issue (2023)

Verigene Enteric Pathogens Test (Luminex) – Test Kit Reliability (2023)

VITROS Troponin I ES Reagent (ORTHO-CLINICAL) – Incorrect Wells (2023)

Tiffin Phaeton (TIFFIN) – Electrical System Fault (2023)

Cardiosave Hybrid IABP (Datascope) – Battery Charging Failure (2023)

Cardiosave Rescue IABP (Datascope) – Battery Charging Failure (2023)

Shoulder GPS Impactor Handle (Exactech) – Mechanism Dislodgement (2023)

Perifix Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Cardiosave Rescue IABP (Datascope) – Power Board Failure (2023)

VERIGENE C. Difficile Test (Luminex) – Test Kit Reliability (2023)

Mercedes-Benz AMG EQS (MERCEDES-BENZ) – Electric Drive Software (2023)

Ergo Impactor Handle (Exactech) – Mechanism Dislodgement (2023)

Entegra Ethos (ENTEGRA) – Solar Panel Detachment (2023)