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BW Lasso Diagnostic EP Catheter (Stryker) – Testing Requirements (2024)

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

FDAMay 10, 2024Nationwide• Stryker Sustainability Solutions

Kosmos iOS Ultrasound (Echonous) – Measurement Inaccuracy (2024)

Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

High

FDAMay 9, 2024AL, AK, AZ +29 more• Echonous Inc

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BW Lasso Diagnostic EP Catheter (Stryker) – Testing Requirements (2024)

Kosmos iOS Ultrasound (Echonous) – Measurement Inaccuracy (2024)

Fixed Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

Exchangeable Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

ZLINE Wall Ovens – Impact Injury Hazard (2024)

Rivian R1S (Rivian) – Airbag Warning Label Missing (2024)

SIORO Children's Robes – Burn Hazard (2024)

Low Dead Space Syringes (Sol-Millennium) – 510(k) Modification (2024)

Toy Pinwheels (Cotton On) – Choking Hazard (2024)

Spin Swivel Chairs – Fall Hazard (2024)

Arctic Cat Catalyst Snowmobiles (Textron) – Crash Hazard (2024)

Hoffman LRF Wire Tensioner (Stryker) – Adjustment Ring Issue (2024)

First Source iQ Flex M Cart (First Source) – Positioning Arm Risk (2024)

Eccentric Tip Syringes (Sol-Millennium) – 510(k) Modification (2024)

Luer Slip Tip Syringes (Sol-Millennium) – 510(k) Modification (2024)

GMC Hummer EV Pickup (GMC) – Electrical System Issue (2024)

Honda Ridgeline (Honda) – Rearview Camera Defect (2024)

Philips Tempus LS Defibrillator (Remote Diagnostic) – ECG Interference (2024)

Syringe Tip Caps (Sol-Millennium) – 510(k) Modification (2024)

First Source Vision M Cart (First Source) – Positioning Arm Risk (2024)