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Allia IGS 7 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

Allia IGS 5 Pulse X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

High

FDAMar 18, 2024Nationwide

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Allia IGS 7 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

Allia IGS 5 Pulse X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

Interact Discovery RT X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

DuraFlow 2 28cm Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip 28cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 24cm Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 55cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 24cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 28cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

Innova IGS 6 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

Innova IGS 5 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

BioFlo DuraMax Sheath Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip 24cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

Alcon Custom Paks Surgical Procedure Pack (Alcon) – Sterile Cannula Issues (2024)

Baxter Seprafilm Adhesion Barrier (Baxter) – Regulatory Approval Missing (2024)

PERLA TL 25D Screw (SPINEART) – Setscrew Insertion Difficulty (2024)