Go Backs

Diagnostic Equipment

AllImplants & Prosthetics(226)Monitoring Devices(264)Diagnostic Equipment(820)Home Healthcare(226)Contact Lenses & Vision(17)Surgical Equipment(892)

820 recalls

per page
GE Healthcare
Medium RiskFDA Device

GE Healthcare: Centricity PACS and Universal Viewer Software Recalled for Patient Data Mix-ups

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

Abbott GmbH: Anti-HCV Reagent Kits Recalled for Falsely Elevated Patient Results

  • Distributed nationwide
  • Sold at Abbott GmbH, Medical laboratories +1 more
  • 12,329 units affected
Recalled
Added
Medium RiskFDA Device

ID NOW COVID-19, Flu, and RSV Test Kits Recalled for High Invalid Result Rates

  • Distributed nationwide
  • Sold at Authorized distributors, Point-of-care facilities
  • 5,383,584 units affected
Recalled
Added
GE Healthcare (China)
Medium RiskFDA Device

GE Healthcare MR Imaging Systems Recalled for Potential Overheating Risk

  • Distributed nationwide
  • Sold at GE Healthcare, Authorized Medical Device Distributors
Recalled
Added
Edan Diagnostics: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Medium RiskFDA Device

Edan Diagnostics: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  • 70,511 units affected
Recalled
Added
Philips North America
Medium RiskFDA Device

Philips North America Llc: Philips Magnetic Resonance (MR) Systems Recalled for Fire Risk

  • Distributed nationwide
  • Sold at specialty medical equipment distributors, direct sales to hospitals
Recalled
Added
Life Technologies
Medium RiskFDA Device

Life Technologies Corporation: Torrent Suite Dx Software Recalled for Cyber Vulnerability and Data Alteration

  • Sold in 5 states
  • Sold at Life Technologies Corporation
Recalled
Added
Elekta
Medium RiskFDA Device

Leksell GammaPlan Treatment Planning Software Recalled for Radiation Risk

  • Sold in 32 states
  • Sold at Direct sales to hospitals and radiotherapy centers
Recalled
Added
Canon Medical System, USA
High RiskFDA Device

Canon Vantage Galan and Titan MRI Systems Recalled for Venting Defect

  • Sold in 19 states
  • Sold at Authorized Medical Device Distributors, Canon Medical Systems direct sales
Recalled
Added
Instrumentation Laboratory
Medium RiskFDA Device

Instrumentation Laboratory: ACL Elite Analyzers Recalled to Remove Specific Test Definitions

  • Distributed nationwide
  • Sold at Clinical hemostasis laboratories, Hospitals
Recalled
Added
Abbott Point Of Care
Medium RiskFDA Device

Abbott i-STAT Blood Analysis Cartridges Recalled for Lack of FDA Clearance

  • Distributed nationwide
  • Sold at Authorized laboratory distributors, Healthcare facilities +1 more
  • 15,625,650 units affected
Recalled
Added
High RiskFDA Device

GE HealthCare Gamma Cameras Recalled for Potential Detector Fall Hazard

  • Distributed nationwide
  • Sold at GE Medical Systems Israel, Functional Imaging, Authorized Medical Device Distributors +1 more
Recalled
Added
Medium RiskFDA Device

3M Company - Health Care Business: 3M Attest Biological Indicators and Challenge Packs Recalled for Melting Caps

  • Distributed nationwide
  • Sold at 3M Health Care
  • 362,748 units affected
Recalled
Added
IMPRIS Imaging
Critical RiskFDA Device

IMRIS Operating Suite MRI Systems Recalled for Helium Leak Risk

  • Distributed nationwide
  • Sold at Direct from manufacturer
  • Helium gas contamination
Recalled
Added
Medium RiskFDA Device

Shimadzu SIL-40C Autosamplers Recalled for Technical Failure Risk

  • Sold in Delaware, Pennsylvania
  • Sold at Authorized Medical Distributors
Recalled
Added
TERRAGENE S.A.
Medium RiskFDA Device

ASP BIOTRACE Process Challenge Devices Recalled for Incorrect Incubation Time

  • Sold in California, Kentucky
  • Sold at Medical device distributors
Recalled
Added
Immunotech A.S.
Medium RiskFDA Device

Immunotech Estrone RIA Kits Recalled for Falsely High Results

  • Sold in North Carolina
  • Sold at Laboratory distributors
Recalled
Added
Medium RiskFDA Device

Siemens RAPIDPoint 500 Wash/Waste Cartridges Recalled for Testing Inaccuracies

  • Distributed nationwide
  • Sold at Medical distributors, Direct sales to healthcare facilities
  • Four complaints were filed; no specific injuries or deaths detailed.
Recalled
Added
Medium RiskFDA Device

Philips Allura Xper Systems Recalled for Mechanical Failure and Collision Risk

  • Distributed nationwide
  • Sold at Authorized Philips medical equipment distributors, Direct hospital sales
Recalled
Added
Echopixel
Medium RiskFDA Device

TRUE 3D VIEWER SYSTEM Recalled for Incorrect Image Orientation

  • Sold in 6 states
  • Sold at Echopixel, Inc.
Recalled
Added
RAYSEARCH LABORATORIES AB
Medium RiskFDA Device

RayStation and RayPlan Software Recalled for Radiation Dose Calculation Error

  • Distributed nationwide
  • Sold at RaySearch Laboratories AB, Authorized Medical Device Distributors
Recalled
Added
GE MEDICAL SYSTEMS, ISRAEL
Medium RiskFDA Device

GE MEDICAL SYSTEMS, ISRAEL LTD.: Venue Go Standard Carts Recalled for Falling Hazard

  • Distributed nationwide
  • Sold at government, military
Recalled
Added
SEDECAL SA
Medium RiskFDA Device

Sedecal Mobile X-Ray Systems Recalled Due to Cleaning and Liquid Damage Risks

  • Sold in California, Illinois, New Jersey
  • Sold at Authorized medical equipment consignees
Recalled
Added
Becton Dickinson
Medium RiskFDA Device

Becton Dickinson & Co.: BD BBL Sensi Discs Recalled for Inaccurate Antibiotic Susceptibility Testing

  • Distributed nationwide
  • Sold at Authorized Medical Distributors, Becton Dickinson direct sales
  • 2,363,168 units affected
Recalled
Added