16 recalls found for Edan Diagnostics. Check if any of your products are affected.
EDAN recalled 195 units of its Central Monitoring System MFM-CMS on October 24, 2025, due to potential cybersecurity issues. The recall follows an FDA letter warning about vulnerabilities that could impact device functionality. Users must stop using the device immediately and follow the manufacturer’s instructions for a remedy.
EDAN recalled 395 units of its Central Monitoring System on October 24, 2025, due to potential cybersecurity risks. The affected models include MFM-CNS and MFM-CNS Lite, which manage critical fetal and maternal health data. Healthcare providers must stop using the devices immediately and follow the recall instructions.
EDAN recalled 3,141 patient monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The recall affects models iM8, iM8A, and iM8B used for monitoring physiological parameters. Healthcare providers must stop using these devices immediately and follow the manufacturer's instructions.
EDAN recalled 379 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models iX10, iX12, and iX15 pose risks to patient safety. Healthcare providers should stop using these devices immediately.
EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to Mexico.
EDAN recalled 14,550 Patient Monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models include iM50, iM60, iM70, and iM80. Healthcare providers should stop using these devices immediately and follow the manufacturer's instructions for remedy.
EDAN recalled 377 iM20 Patient Monitors on October 24, 2025, due to cybersecurity issues. The recall affects devices distributed nationwide in the U.S. and Mexico. Healthcare providers must stop using this device immediately.
EDAN recalled 11,987 iM3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity risks. The recall affects devices distributed across the United States and Mexico.
EDAN recalled 136 vital signs monitors on October 24, 2025, due to potential cybersecurity issues. The devices include models iM3s, iM3As, iM3Bs, and iHM3s. Patients and healthcare providers must stop using these monitors immediately and follow recall instructions.
EDAN recalled 13,934 M3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity issues. The recall affects devices distributed in multiple U.S. states and Mexico. Healthcare professionals must stop using the device immediately and follow manufacturer instructions.
EDAN recalled 12,201 Vital Signs Monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected M3A model poses a high risk to patient safety by compromising monitoring accuracy. Users must stop using the devices immediately and follow recall instructions.
EDAN recalled 354 units of its M3B Vital Signs Monitor on October 24, 2025, due to potential cybersecurity vulnerabilities. The recall affects devices distributed nationwide in the U.S. and Mexico. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's instructions for returning the product.
EDAN recalled 342 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models affected include elite V5, elite V6, and elite V8. Healthcare providers and patients should stop using these devices immediately.
EDAN recalled 3,721 fetal monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models, F2 and F3, are used to monitor pregnant women and fetuses after 28 weeks of gestation. Healthcare providers must stop using these devices immediately and follow recall instructions.
EDAN recalled 1,457 iT20 telemetry transmitters on October 24, 2025, due to potential cybersecurity issues. The recall affects devices distributed in the United States and Mexico. Healthcare providers and patients must immediately discontinue use of the device.
EDAN recalled 3,518 fetal and maternal monitors on October 24, 2025, due to potential cybersecurity issues. Affected models include F6, F9, F6 Express, and F9 Express. The recall impacts devices distributed in the U.S. and Mexico.