Diagnostic Equipment

Cellavision DI-60 Morphology Analyzers Recalled for Result Misattribution

• Sold in Florida
• Sold at Authorized distributors

CareFusion: NicoletOne vEEG Systems Recalled Due to Software Protocol Errors

• Sold in Florida, New Jersey, Pennsylvania

Philips Vue Motion Software Recalled for Image Sequencing Error

• Distributed nationwide
• Sold at Authorized Medical Device Distributors, Direct Sales

RefleXion X1 Radiotherapy System Recalled for Software Defect

• Sold in 8 states
• Sold at Reflexion Medical, Inc. (Direct to hospitals/clinics)

Accriva Diagnostics, Inc.: AVOXimeter 1000E Oximeters Recalled for Incorrect Patient Results

• Sold in Arizona

Esaote Endocavity Ultrasonic Probes Recalled Due to Liquid Leak Risk

• Sold in North Carolina, Texas
• Sold at Direct distribution

ID NOW Influenza A & B 2 Kits Recalled for Increased Invalid Test Rates

• Distributed nationwide
• Sold at authorized distributors
• 111,984 units affected

GE Medical Systems, LLC: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

Welch Allyn Spot Vision Screener VS100 Recalled for Display Flickering

• Sold in 14 states
• Sold at Authorized medical distributors, Direct sales

Datascope Cardiosave Battery Charging Station Recalled for Charging Failure

• Sold in 11 states
• Sold at Hospital supply distributors, Direct sales from Getinge/Datascope

Aptima HPV Assay Recalled for Potential False Negative Results

• Sold in 9 states
• Sold at Clinical laboratories, Healthcare facilities

Diagnostica Stago STA Liatest D-Di Kits Recalled for Inaccurate Results

• Distributed nationwide
• Sold at Professional laboratory suppliers
• 34,000 units affected

MicroScan Neg MIC 56 Panels Recalled for Potential Contamination

• Sold in 12 states
• Sold at Direct from manufacturer, Laboratory distributors
• Unknown biological contamination contamination

Imactis CT-Navigation Systems Recalled for Needle Trajectory Issue

• Distributed nationwide
• Sold at GE Medical Systems, Authorized Medical Device Distributors

BiDop 3 Pocket Doppler Recalled for Unapproved Fetal Use Labeling

• Sold in 16 states
• Sold at Authorized distributors, Medical equipment suppliers

Philips Ultrasound Transducers Recalled for Labelling Clarification

• Distributed nationwide
• Sold at Authorized Medical Device Distributors, Direct Sales

BD Kiestra ReadA Lab Automation Recalled for Software Connectivity Issue

• Sold in 6 states
• Sold at Direct from manufacturer

Atellica CH Enzymatic Hemoglobin A1c Recalled for Inaccurate Results

• Distributed nationwide
• Sold at Clinical laboratories, Hospitals
• 21,291 units affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

• 20,389 units affected

Cardinal Health Monoject Tuberculin Syringes Recalled for Mislabeling

• Distributed nationwide
• Sold at Authorized medical distributors
• 198,900 units affected

GE Healthcare SIGNA Premier MR Scanners Recalled for Risk of Projectile Injury

• Sold in 9 states
• Sold at GE Healthcare LLC
• Ferrous (steel) fittings contamination

Oxoid Microbact Listeria 12L Identification Kits Recalled for Inaccurate Results

• Sold in Georgia, California
• Sold at Laboratory suppliers, Thermo Fisher Scientific

MicroScan Neg MIC 3J Diagnostic Panels Recalled for Dosing Error

• Distributed nationwide
• Sold at International distribution, Authorized distributors in Japan

IBA Proton Therapy System PROTEUS 235 Recalled for Beam Control Defect

• Sold in Florida
• Sold at Direct distribution