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Propel Mini Sinus Implant (Intersect ENT) – Label Error (2022)

Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

Moderate

FDAOct 21, 2022Nationwide• Intersect ENT, Inc.

Philips ProxiDiagnost N90 (Philips) – Tabletop Cable (2022)

Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking

Moderate

FDAOct 21, 2022Nationwide• Philips North America Llc

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Propel Mini Sinus Implant (Intersect ENT) – Label Error (2022)

Philips ProxiDiagnost N90 (Philips) – Tabletop Cable (2022)

Busse Spine Injection Tray (Busse) – Surgical Drape Problem (2022)

ROi Spine Pack (ROi) – Surgical Drape Concern (2022)

ROi Lateral Shoulder Kit (ROi) – Surgical Drape Problem (2022)

ROi Total Joint Kit (ROi) – Surgical Drape Concern (2022)

ROi Foot Pack (ROi) – Surgical Drape Concern (2022)

ROi Hip Arthroscopy Kit (ROi) – Surgical Drape Problem (2022)

ROi Spine Pack (ROi) – Surgical Drape Problem (2022)

ROi Laminectomy Kit (ROi) – Surgical Drape Issue (2022)

ROi Cardiac Kit (ROi) – Surgical Drape Problem (2022)

ROi Retinal Pack (ROi) – Surgical Drape Concern (2022)

ROi Basic Neuro Kit (ROi) – Surgical Drape Issue (2022)

ROi Vitrectomy Pack (ROi) – Surgical Drape Issue (2022)

ROi Hand Pack (ROi) – Surgical Drape Problem (2022)

ROi Spine Kit (ROi) – Surgical Drape Concern (2022)

ROi Neuro Tray (ROi) – Surgical Drape Issue (2022)

ROi Neuro Pack (ROi) – Surgical Drape Issue (2022)

ROi Shoulder Arthroscopy Kit (ROi) – Surgical Drape Concern (2022)

ROi Kyphoplasty Kit (ROi) – Surgical Drape Concern (2022)