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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

Galt Medical

Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Surgical Instruments View Details →

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

Merge Healthcare

Class I - Dangerous

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

Aug 7, 2017 Diagnostic Equipment Nationwide View Details →

Discovery MI Digital Ready

GE Healthcare

Class I - Dangerous

DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

Integra LifeSciences

Class I - Dangerous

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Jun 29, 2018 Diagnostic Equipment Nationwide View Details →

Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

Galt Medical

Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Other Medical Devices View Details →

Optima CT 520

GE Healthcare

Class I - Dangerous

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

Optima CT 540

GE Healthcare

Class I - Dangerous

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

Nicolet¿ Ambulatory EEG

Natus Neurology

Class I - Dangerous

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

Feb 1, 2018 Other Medical Devices Nationwide View Details →

1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

Galt Medical

Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Other Medical Devices View Details →

1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

Galt Medical

Class I - Dangerous

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

May 2, 2018 Other Medical Devices View Details →