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Showing 4761–4780 of 8393 results

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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

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.

High

FDAJul 13, 2023Nationwide• Siemens Medical Solutions USA, Inc.

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

PASS LP (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

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K (Medtronic Sofamor Danek USA, Inc) – incorrect laser marking - solera awl ... (2023)

Incorrect Laser Marking - Solera Awl Tip Tap

FDAJul 12, 2023Nationwide• Medtronic Sofamor Danek USA, Inc

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (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

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x (Beckman Coulter Inc.) – lipemic interference failed to meet t... (2023)

Lipemic interference failed to meet the performance specification listed within the IFU.

FDAJul 12, 2023AL, AZ, AR +40 more• Beckman Coulter Inc.

IMPIX C+ (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

IMPIX ALIF S/A (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

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753,... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (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

Carina Sub-Acute Care Ventilator (Draeger Medical, Inc.) – presence of polyether polyurethane (p... (2023)

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

FDAJul 12, 2023Nationwide• Draeger Medical, Inc.

IMPIX TLIF (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

FreeStyle Libre 2 Readers (Abbott) – Sensor Start Issue (2023)

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

FDAJul 12, 2023Nationwide• Abbott Diabetes Care, Inc.

IMPIX ALIF (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

IMPIX DLIF (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

Air/Water Valve (Olympus) – Valve Functionality Loss (2023)

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

FDAJul 12, 2023Nationwide• Olympus Corporation of the Americas

GRANVIA-C (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

The following Pro.specta Emission Computed Tomography Sys... (Siemens Medical Solutions USA, Inc.) – during a whole-body planar scan with ... (2023)

During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

FDAJul 12, 2023ID, KS, MA +4 more• Siemens Medical Solutions USA, Inc.

IMPIX MANTA (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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