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Showing 4741–4760 of 8393 results

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Freedom Boom Models (IHB) – Suspension Arm Weakness (2023)

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

FDAJul 19, 2023AL, AZ, AR +33 more• IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands

Proclaim Plus 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Neodent Healing Abutment (Preat) – Dimensional Gap Risk (2023)

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Moderate

FDAJul 18, 2023CA, FL, NJ +4 more• Preat Corp

Portex Hydrophobic Filter (Smiths Medical) – Labeling Error (2023)

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

FDAJul 18, 2023Nationwide• Smiths Medical ASD Inc.

Proclaim XR 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Proclaim DRG Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Proclaim Plus 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Neodent Healing Abutment (Preat) – Dimensional Gap Risk (2023)

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

FDAJul 18, 2023CA, FL, NJ +4 more• Preat Corp

Proclaim XR 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Infinity 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Infinity 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDAJul 18, 2023Nationwide• Abbott Medical

Neodent Healing Abutment (Preat) – Dimensional Gap Risk (2023)

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

FDAJul 18, 2023CA, FL, NJ +4 more• Preat Corp

Aquilex Fluid System (WOM) – Volume Display Limit (2023)

The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

FDAJul 17, 2023Nationwide• WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany

RayCare Software (RaySearch) – Allergy Warning Issue (2023)

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

FDAJul 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Copan Transfer Pipette (Copan) – Aspiration Defect (2023)

Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance

FDAJul 14, 2023CA• Copan Diagnostics Inc

MobileLink Acetabular Cup (Waldemar Link) – Incorrect Offset (2023)

Product is labeled with incorrect offset.

FDAJul 14, 2023AL, NV, NJ• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Q2 Multiport Extension Set (Quest Medical) – Administration System (2023)

For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

FDAJul 14, 2023AL, CA, CO +16 more• Quest Medical, Inc.

L-Aneurysm Clip (Peter Lazic) – Incorrect Color (2023)

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

FDAJul 14, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

Chevalier Valvulotome (LeMaitre) – Cutter Surface Defect (2023)

Laceration Risk

Burrs (molding flash) on the cutter may tear the harvested vien

FDAJul 13, 2023Nationwide• LeMaitre Vascular, Inc.

ACL TOP Family Analyzer (Instrumentation Lab) – Result Misidentification (2023)

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

FDAJul 13, 2023Nationwide• Instrumentation Laboratory

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