Other Medical Devices Recalls

ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

Cardinal Health 200

Class I - Dangerous

Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

Mar 22, 2019 Other Medical Devices Nationwide View Details →

ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

Conmed

Class I - Dangerous

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Mar 21, 2019 Other Medical Devices Nationwide View Details →

ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

Cardinal Health 200

Class I - Dangerous

Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

Mar 22, 2019 Other Medical Devices Nationwide View Details →

ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

Conmed

Class I - Dangerous

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Mar 21, 2019 Other Medical Devices Nationwide View Details →

Atellica IM 1600 Analyzer, Material Number 11066000

Siemens Healthcare Diagnostics

Class I - Dangerous

There were multiple issues identified in the system software which required an update.

Mar 7, 2019 Other Medical Devices Nationwide View Details →

ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

Conmed

Class I - Dangerous

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Mar 21, 2019 Other Medical Devices Nationwide View Details →

Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

Medtronic

Class I - Dangerous

The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.

Jul 4, 2018 Other Medical Devices View Details →

ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

Cardinal Health 200

Class I - Dangerous

Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

Mar 22, 2019 Other Medical Devices Nationwide View Details →

ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

Conmed

Class I - Dangerous

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Mar 21, 2019 Other Medical Devices Nationwide View Details →

Atellica Sample Handler Prime, Material Number 11069001

Siemens Healthcare Diagnostics

Class I - Dangerous

There were multiple issues identified in the system software which required an update.

Mar 7, 2019 Other Medical Devices Nationwide View Details →

Atellica IM 1300 Analyzer, Material Number 11066001

Siemens Healthcare Diagnostics

Class I - Dangerous

There were multiple issues identified in the system software which required an update.

Mar 7, 2019 Other Medical Devices Nationwide View Details →

ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

Conmed

Class I - Dangerous

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product

Mar 21, 2019 Other Medical Devices Nationwide View Details →

SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA

Class I - Dangerous

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

Feb 14, 2019 Other Medical Devices Nationwide View Details →

cobas e 801 immunoassay analyzer

Roche Diagnostics

Class I - Dangerous

The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.

Mar 15, 2019 Other Medical Devices Nationwide View Details →

Fetal Spiral Electrode, Model No. 9898 031 37631

Philips North America

Class I - Dangerous

During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

Jan 25, 2019 Other Medical Devices Nationwide View Details →

SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA

Class I - Dangerous

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

Feb 14, 2019 Other Medical Devices Nationwide View Details →

SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA

Class I - Dangerous

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

Feb 14, 2019 Other Medical Devices Nationwide View Details →

MRIdian Linac Radiation Therapy System, Model 20000.

Viewray

Class I - Dangerous

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

Mar 18, 2019 Other Medical Devices View Details →

SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA

Class I - Dangerous

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

Feb 14, 2019 Other Medical Devices Nationwide View Details →

Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

Thoratec

Class I - Dangerous

Small black plastic particle was observed in the left ventricle during implant procedure.

Mar 1, 2019 Other Medical Devices Nationwide View Details →