Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(229)Monitoring Devices(252)Diagnostic Equipment(818)Home Healthcare(215)Contact Lenses & Vision(17)Surgical Equipment(896)

818 recalls

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Abbott Laboratories
Medium RiskFDA Device

Abbott Laboratories: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

  • 11,653 units affected
Recalled
Added
Carestream Health
Medium RiskFDA Device

Carestream Health, Inc.: DRX-Revolution Mobile X-Ray Systems Recalled for Generator Thermal Overload

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Direct Hospital Sales
Recalled
Added
Medium RiskFDA Device

Artis Pheno X-Ray Systems Recalled for Startup Movement Defects

  • Sold in 12 states
  • Sold at Authorized Medical Device Distributors, Siemens Medical Solutions USA, Inc.
Recalled
Added
Reichert
Medium RiskFDA Device

Reichert Phoroptor VRx Digital Refraction System Recalled for Head Detachment Risk

  • Distributed nationwide
  • Sold at authorized medical equipment distributors
Recalled
Added
Becton Dickinson
Low RiskFDA Device

BD BBL TB Stain Kit K Recalled for Incorrect Expiration Date

  • Sold in 14 states
  • Sold at Laboratory suppliers, Medical distributors
Recalled
Added
GE Medical Systems, SCS
Medium RiskFDA Device

GE Medical Systems, SCS: Senographe Pristina X-Ray Systems Recalled for Audible Signal Failure

  • Distributed nationwide
  • Sold at GE Medical Systems, Authorized Medical Device Distributors
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recalled for Barcode Errors

  • Sold in 26 states
  • Sold at Authorized Medical Device Distributors, Direct Sales
Recalled
Added
Merge Healthcare
Medium RiskFDA Device

Merge Cardio Software Recalled for Inconsistent Patient Measurements

  • Distributed nationwide
  • Sold at Authorized medical software distributors, Direct sales to hospitals and clinics
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics Inc: RAPIDPoint 500e Blood Gas System Recalled for Incorrect Sample Labeling

  • Sold in 5 states
  • Sold at Siemens Healthineers, Medical device distributors
Recalled
Added
WOM World Of Medicine AG
Medium RiskFDA Device

WOM World Of Medicine AG: Aquilex Fluid Control System Recalled for Fluid Overload Risk

  • Distributed nationwide
  • Sold at Authorized medical device distributors, Hospitals +1 more
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter, Inc.: Access 2 Immunoassay System Analyzers Recalled for Reagent Carousel Motion Errors

  • Sold in 9 states
  • Sold at Beckman Coulter, Inc., Direct medical distribution
Recalled
Added
Topcon Medical Systems
Medium RiskFDA Device

IMAGEnet 6 Software Recalled for Inaccurate Diagnostic Map Overlays

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Topcon Medical Systems
Recalled
Added
AB Sciex
High RiskFDA Device

AB Sciex, LLC: Mass Spectrometers Recalled for Fire and Component Ejection Risks

  • Distributed nationwide
  • Sold at AB Sciex, LLC
Recalled
Added
Medium RiskFDA Device

Siemens Medical Solutions USA, Inc: Radiographic X-Ray Tables Recalled Due to Overheating and Fire Risk

  • Distributed nationwide
  • Sold at Siemens Medical Solutions USA, Inc, authorized medical equipment distributors
Recalled
Added
Beckman Coulter
Medium RiskFDA Device

Beckman Coulter IMMAGE IgM Reagent Recalled for Lowered Sensitivity

  • Sold in 15 states
  • Sold at Authorized clinical laboratories, Medical device distributors
  • 12,102 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips Incisive CT and CT 5300 Systems Recalled for Detachment Risk

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, Direct Sales to Hospitals and Clinics
Recalled
Added
Medium RiskFDA Device

Siemens epoc NXS Host Recalled for Software Glitch and Patient Name Errors

  • Distributed nationwide
  • Sold at Siemens Healthcare Diagnostics, Medical Supply Distributors
  • 13,279 units affected
Recalled
Added
BioFire Diagnostics
Medium RiskFDA Device

BioFire Respiratory Panel 2.1 plus Kits Recalled for False Negative Results

  • Sold at Authorized medical distributors
Recalled
Added
Medium RiskFDA Device

Mirion Technologies (Capintec), Inc.: Captus 4000e Thyroid Uptake Systems Recalled for Falling Collimator Risk

  • Distributed nationwide
  • Sold at Nuclear Medicine Departments, Medical Equipment Distributors
Recalled
Added
Microbiologics
Medium RiskFDA Device

Microbiologics KWIK-STICK Quality Control Kits Recalled for Wrong Microorganisms

  • Sold in California, Pennsylvania
  • Sold at Microbiologics Inc
  • Staphylococcus aureus, Oligella urethralis contamination
Recalled
Added
Medium RiskFDA Device

Siemens Medical Solutions USA, Inc.: ACUSON Ultrasound Systems Recalled for Cardiac Measurement Software Error

  • Sold in 40 states
  • Sold at Siemens Medical Solutions USA, Inc.
Recalled
Added
PATH
Medium RiskFDA Device

Madsen AccuScreen Probes Recalled for Potential False Hearing Test Results

  • Sold in Wisconsin
  • Sold at Authorized medical device distributors, Hearing diagnostic equipment suppliers
Recalled
Added
SunMed
Critical RiskFDA Device

Broselow Pediatric Emergency Rainbow Tapes Recalled for Dosing Errors

  • Distributed nationwide
  • Sold at Authorized medical distributors
  • 116,356 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America: Ingenia Ambition X and S MRI Systems Recalled for Loss-of-Field Shutdown

  • Sold in 24 states
  • Sold at Philips North America, Medical facilities
Recalled
Added