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DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Unspecified Issue (2024)

XXX

FDAMar 18, 2024VA• Angiodynamics, Inc.

Allia IGS 7 OR 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

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DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Unspecified Issue (2024)

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

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

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

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

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

LightStrike Blackout Curtains (Xenex) – UV Protection Limitation (2024)

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

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

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

Palindrome Precision HSI Chronic Catheter (Unknown) – Incorrect Heparin Coating (2024)

Palindrome Precision H Chronic Catheter (Unknown) – Incorrect Heparin Coating (2024)

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

Prelude Guide Sheath Roadster (Merit Medical) – Incorrect Dilator Risk (2024)

Keller Funnel 2 (Allergan) – Implant Coating Issue (2024)

Medline Delivery Kit (Medline) – Weak Seal Concerns (2024)

Medline Cath Lab Kit (Medline) – Weak Seal Concerns (2024)

VITEK 2 AST Test Kits (Biomerieux) – Concentration Errors (2024)

Medline Open Heart Kit (Medline) – Weak Seal Concerns (2024)

Medline Retrograde Kit (Medline) – Weak Seal Concerns (2024)