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Showing 4921–4940 of 8393 results

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Epoc BGEM BUN Test Card (Siemens) – Glucose Result Discrepancy (2023)

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

FDAJun 1, 2023AL, AZ, AR +23 more• Siemens Healthcare Diagnostics Inc

Epoc BGEM Veterinary Test Card (Siemens) – Glucose Result Discrepancy (2023)

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

FDAJun 1, 2023AL, AZ, AR +23 more• Siemens Healthcare Diagnostics Inc

Megadyne MEGA SOFT Universal Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

MICRO-X Rover Mobile X-ray System (Micro-X) – Exposure Time Limitation (2023)

Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.

FDAMay 31, 2023Nationwide• Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia

Profile Zero Auto-Drive Screw (Osteomed) – Screwhead Size Risk (2023)

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

FDAMay 31, 2023Nationwide• Osteomed, LLC

Profile 0 AutoDrive Screw (Osteomed) – Screwhead Size Risk (2023)

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

FDAMay 31, 2023Nationwide• Osteomed, LLC

COULTER DxH Diluent (Beckman Coulter) – Specification Deviation (2023)

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

FDAMay 31, 2023Nationwide• Beckman Coulter, Inc.

Trexo Device (Trexo Robotics) – Electrical Functionality Risks (2023)

Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

FDAMay 31, 2023Nationwide• Trexo Robotics Holdings Inc.

Haemophilus Test Medium (Remel) – Performance Uncertainty (2023)

The test medium may not perform as intended.

FDAMay 31, 2023Nationwide• Remel, Inc

UFSK Treatment Chair 500 XLE (UFSK) – Drive Mechanism Wear (2023)

Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position

FDAMay 31, 2023Nationwide• UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany

GE Vivid S60N Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

VERITAS Infusion Packs (Johnson & Johnson) – Housing Weld Defect (2023)

Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

FDAMay 30, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Acetabular Bearing (Synovo) – FDA Clearance Concern (2023)

Medical device components were marketed without FDA clearance

FDAMay 30, 2023Nationwide• Synovo Production

GE Vivid S60 Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

GE Vivid S70 Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

Femoral Resurfacing Cup (Synovo) – FDA Clearance Concern (2023)

Medical device components were marketed without FDA clearance

FDAMay 30, 2023Nationwide• Synovo Production

Prima TT Genoid Baseplate (Limacorporate) – Hole Specification Issue (2023)

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

FDAMay 30, 2023Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Prima TT Genoid Monoblock Baseplate (Limacorporate) – Hole Specification Issue (2023)

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

FDAMay 30, 2023Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Acetabular Fixation Cup (Synovo) – FDA Approval Missing (2023)

Medical device components were marketed without FDA clearance and without FDA approval

FDAMay 30, 2023Nationwide• Synovo Production

Alinity ci-series Control Module (Abbott) – System Performance Issues (2023)

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

FDAMay 30, 2023AL, AK, AZ +43 more• Abbott Laboratories

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