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Other Medical Devices

Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland)

Class I - Dangerous

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

Oct 18, 2018 Other Medical Devices Nationwide View Details →

Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland)

Class I - Dangerous

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

Oct 18, 2018 Other Medical Devices Nationwide View Details →

Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland)

Class I - Dangerous

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

Oct 18, 2018 Other Medical Devices Nationwide View Details →

Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

Capintec

Class I - Dangerous

There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.

Nov 5, 2018 Other Medical Devices Nationwide View Details →

Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Discolored powder has confirmed the presence of a foreign substance

Oct 9, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Discolored powder has confirmed the presence of a foreign substance

Oct 9, 2018 Other Medical Devices Nationwide View Details →

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Discolored powder has confirmed the presence of a foreign substance

Oct 9, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

Maquet Cardiovascular Us Sales

Class I - Dangerous

There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.

Oct 25, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

Maquet Cardiovascular Us Sales

Class I - Dangerous

Oct 25, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Oct 17, 2018 Other Medical Devices Nationwide View Details →

PremierPro Aluminum Adjustable Walker

SVS

Class I - Dangerous

This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.

Oct 1, 2018 Other Medical Devices View Details →

Insulia Diabetes Management Companion

Voluntis

Class I - Dangerous

The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue.

Oct 8, 2018 Other Medical Devices View Details →

Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

GE Healthcare

Class I - Dangerous

Potential electric leakage affecting the user.

Sep 25, 2018 Other Medical Devices Nationwide View Details →

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