FDA Device Recalls

Class IICompleted

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

Philips North America Llc

Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

March 29, 2022 · DeviceView details →

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

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YelloPort Elite Universal Seal. For use in laparoscopic procedures.

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LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

illumina Model NextSeq 550 Dx REF 20005715

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CardioTek EP-TRACER Software V2.x.