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Colonoscope PCF-H180AL (Olympus) – Adhesive Deficiency (2024)

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Moderate

FDAJan 11, 2024Nationwide• Olympus Corporation of the Americas

Apollo Onyx Delivery Microcatheter (Micro Therapeutics) – Indications Mismatch (2024)

European version of microcatheter were distributed within US which contain a different "Indications for Use".

Low

FDAJan 11, 2024Nationwide• Micro Therapeutics, Inc.

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Colonoscope PCF-H180AL (Olympus) – Adhesive Deficiency (2024)

Apollo Onyx Delivery Microcatheter (Micro Therapeutics) – Indications Mismatch (2024)

Brasseler Dental Bur (Brasseler) – Grip Detail Defect (2024)

Colonoscope CF-Q180AL (Olympus) – Adhesive Deficiency (2024)

Colonoscope PCF-Q180AL (Olympus) – Adhesive Deficiency (2024)

Colonoscope CF-H180AL (Olympus) – Adhesive Deficiency (2024)

Colonoscope CF-HQ190I (Olympus) – Adhesive Deficiency (2024)

Synapse PACS v7.3.000 (Fujifilm) – Measurement Error (2024)

Synapse PACS v7.2.200 (Fujifilm) – Measurement Error (2024)

Synapse PACS v7.1.000 (Fujifilm) – Measurement Error (2024)

Synapse PACS v7.1.000US (Fujifilm) – Measurement Error (2024)

AirLife Resuscitator (Vyaire) – Component Defect (2024)

Synapse PACS v7.2.100 (Fujifilm) – Measurement Error (2024)

Synapse PACS v7.2.000 (Fujifilm) – Measurement Error (2024)

Custodiol HTK Solution (Dr. Franz Koehler) – Particle Presence (2024)

Medtronic Invos Sensor Cable (Covidien) – Connector Defect (2024)

Medtronic Invos Infant Sensor Cable (Covidien) – Connector Defect (2024)

Abbott Reproductive Control Set (McKesson) – Temperature Excursion (2024)

Laparoscopic Instrument (Silex) – Insulation Gap (2024)

Abbott i-STAT Control (McKesson) – Temperature Excursion (2024)