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Showing 6781–6800 of 11714 results

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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

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

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

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

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

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

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

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

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.

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

Snowden-Pencer MIS Grasper (Carefusion) – Rotation Knob Defect (2023)

Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

FDAJul 13, 2023Nationwide• Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

ACUSON Redwood Ultrasound (Siemens) – Preset Compatibility Problem (2023)

If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.

FDAJul 13, 2023Nationwide• Siemens Medical Solutions USA, 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

Embrace2 Device (Empatica) – Battery Life Limitation (2023)

May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

FDAJul 13, 2023Nationwide• EMPATICA SRL Via Enrico Stendhal

Plum 360 Infusion System (ICU Medical) – Alarm Signal Issue (2023)

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

FDAJul 13, 2023Nationwide• ICU Medical Inc

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.

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Uro Kid Support Capsules (Global Vitality) – E. Coli Risk (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Serious Brain Enhancer Capsules (Global Vitality) – E coli contamination (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

IMPIX 3D (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

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