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CyberKnife Treatment System (Accuray) – Snap Ring Detachment (2024)

Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.

Moderate

FDADec 23, 2024Nationwide• Accuray Incorporated

AnchorFast Oral Endotracheal Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Moderate

FDADec 23, 2024Nationwide• Hollister Incorporated

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CyberKnife Treatment System (Accuray) – Snap Ring Detachment (2024)

AnchorFast Oral Endotracheal Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Lev5 Susceptibility Discs (Oxoid) – Mislabeling Risk (2024)

AnchorFast Guard Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

ETHIBOND EXCEL Polyester Suture (Ethicon) – Packaging Seal Defect (2024)

Smart Drive MX2+ SpeedControl Dial (Max Mobility) – Circuit Board Fault (2024)

Life 2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

PROLENE Polypropylene Suture (Ethicon) – Packaging Seal Issue (2024)

Baxter Solution Set (Baxter) – Inverted Side Clamps (2024)

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Detachment (2024)

PERMA-HAND Silk Suture (Ethicon) – Packaging Seal Defect (2024)

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)

AXIOS Stent Delivery System (Boston Scientific) – Stent Saddle Problem (2024)

Lipoprotein (a) Test (Randox) – 510(k) Compliance Issue (2024)

Repeater Bone Tamp (Integrity Implants) – Component Incompatibility (2024)

Clearlink System Solution Set (Baxter) – Inverted Side Clamps (2024)

Continu-Flo Solution Set (Baxter) – Inverted Side Clamps (2024)

HOT AXIOS Stent Delivery System (Boston Scientific) – Outer Sheath Issue (2024)

8MM Long Bipolar Grasper (Intuitive Surgical) – Grip Cable Failure (2024)