Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(228)Monitoring Devices(259)Diagnostic Equipment(818)Home Healthcare(219)Contact Lenses & Vision(17)Surgical Equipment(898)

818 recalls

per page
FUJIFILM Healthcare Americas
Medium RiskFDA Device

FUJIFILM Healthcare Americas Corporation: Synapse PACS Software Recalled for Incorrect Medical Measurements

  • Distributed nationwide
  • Sold at Authorized Medical Device Distributors, FUJIFILM Direct Sales
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Philips CT Scanners and Simulators Recalled for Imaging Software Defects

  • Distributed nationwide
  • Sold at Philips North America Llc
Recalled
Added
Cepheid
Medium RiskFDA Device

Cepheid Xpert MTB/RIF Recalled for Stability Testing Failure

  • Distributed nationwide
  • Sold at Specialty medical distributors, Direct laboratory sales
Recalled
Added
Philips Ultrasound
Medium RiskFDA Device

Lumify Ultrasound Systems Recalled for Failed Imaging on iOS 18

  • Sold in 49 states
  • Sold at Authorized Philips Medical Distributors, Healthcare Equipment Dealers
Recalled
Added
MedicalCommunications
Medium RiskFDA Device

HEYEX 2 and HEYEX PACS Software Recalled for Inaccurate Area Measurements

  • Distributed nationwide
  • Sold at Medical software distributors
Recalled
Added
Randox Laboratories
Low RiskFDA Device

Randox Laboratories Ltd.: Evidence MultiSTAT Analyzer Recalled for Potential Testing Result Delays

  • Distributed nationwide
  • Sold at Randox Laboratories Ltd.
Recalled
Added
Medium RiskFDA Device

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion X-Ray Systems Recalled for Software Issue Causing System Restarts

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

GE HealthCare OEC 9800 and 9900 C-arms Recalled for Radiation Risk

  • Distributed nationwide
  • Sold at Healthcare facilities, Hospitals +1 more
Recalled
Added
Oculus Optikgeraete
Medium RiskFDA Device

Oculus Optikgeraete GMBH: Oculus Diagnostic Devices Recalled for Potential Incorrect Eye Measurements

  • Sold in 11 states
  • Sold at Authorized Medical Device Distributors
Recalled
Added
Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Adult Blood and Blood Culture Kits Recalled for Possible Expired Components

  • Distributed nationwide
  • Sold at Medline Industries, LP
  • 26,715 units affected
Recalled
Added
Philips Healthcare (Suzhou)
Medium RiskFDA Device

Philips Incisive CT Scanners Recalled for Potential Incomplete Scans

  • Distributed nationwide
  • Sold at Medical device distributors, Direct sales to hospitals and clinics
Recalled
Added
GE Healthcare (China)
Medium RiskFDA Device

GE Discovery, Optima, and Revolution CT Systems Recalled for Image Rotation

  • Distributed nationwide
  • Sold at GE Healthcare Authorized Dealers
Recalled
Added
Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Urinary/Cerebrospinal Fluid Protein Reagents Recalled for Inaccurate Results

  • Sold in 15 states
  • Sold at Siemens Healthcare Diagnostics, Medical laboratories +1 more
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips MobiView and SmartPath MRI Upgrades Recalled for Imaging Errors

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

IBA myQA iON Software Recalled for Potential Incorrect Analysis Results

  • Sold in 7 states
  • Sold at Direct Sales
Recalled
Added
PATH
Medium RiskFDA Device

PATH: SENTIERO and AuDX PRO Hearing Devices Recalled for Technical Distortions

  • Sold in 4 states
Recalled
Added
Remel
Medium RiskFDA Device

Remel Agar Culture Media Recalled for Listeria Contamination

  • Distributed nationwide
  • Sold at Clinical laboratory distributors
  • Listeria monocytogenes contamination
Recalled
Added
Medium RiskFDA Device

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper Systems Recalled Due to Table Pivot Brake Failure

  • Distributed nationwide
  • Sold at authorized medical distributors
Recalled
Added
Medium RiskFDA Device

BD FACS 7-Color Setup Beads Recalled Due to Instrument Setup Errors

  • Sold in 37 states
  • Sold at BD Bio Sciences authorized distributors
Recalled
Added
Nova Biomedical
Medium RiskFDA Device

Nova Biomedical Corporation: Prime Plus Analyzers Recalled for Potential Erroneous Patient Results

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

GE OEC 3D, Elite, 9900, and 9800 X-ray Systems Recalled for Potential Oil Leak

  • Sold in 44 states
  • Sold at GE OEC Medical Systems, Inc, Authorized medical equipment distributors
Recalled
Added
Foundation Medicine
Medium RiskFDA Device

FoundationOne Diagnostic Reports Recalled for Missing Claims Information

  • Sold in 29 states
  • Sold at Foundation Medicine, Inc., Healthcare Providers
Recalled
Added
SEDECAL SA
Medium RiskFDA Device

SEDECAL SA: MobileDiagnost wDR Systems Recalled for Unintended Movement Risk

  • Distributed nationwide
  • Sold at Government distribution, Direct medical device distributors
Recalled
Added
Medium RiskFDA Device

Various Diagnostic Test Strips Recalled for Lack of Legal Marketing Clearance

  • Sold in Texas, Georgia, California
  • Sold at Authorized distributors
  • 139,966 units affected
Recalled
Added