Wisconsin recalls

Philips released a software update (version 4.5.0) for the Patient Information Center iX that changes how mobile event notifications are filtered. The system makes these changes without alerting users, so staff may not realize their notification settings have been altered.

The FDA identified potential cybersecurity issues with Edan's iT20 telemetry transmitter, a device used in hospitals to monitor patient heart rhythm and oxygen levels wirelessly. The company received an FDA notice asking it to address these vulnerabilities. No injuries have been reported.

The FDA identified potential cybersecurity issues with Edan iM8, iM8A, and iM8B patient monitors. These devices are used in medical settings to continuously monitor heart rhythm, blood oxygen, blood pressure, and other vital signs. The vulnerability could potentially allow unauthorized access to the device or its data.

The FDA identified potential cybersecurity issues with certain Edan M3A Vital Signs Monitors used in healthcare settings. These portable devices measure blood pressure, oxygen levels, and temperature. The FDA sent a letter to the manufacturer asking them to address the security vulnerabilities.

The FDA identified potential cybersecurity issues with Edan's M3B Vital Signs Monitor, a hospital device that tracks oxygen levels, heart rate, and CO2. Certain serial numbers manufactured between 2015 and 2024 may be affected. No patient injuries have been reported.

Edan Diagnostics' MFM-CNS and MFM-CNS Lite clinical software systems for fetal and maternal monitoring have potential cybersecurity vulnerabilities. The FDA identified these issues and requested action from the manufacturer. No patient harm has been reported.

Edan Diagnostics' MFM-CMS central monitoring system has potential cybersecurity issues that could allow unauthorized access to patient monitoring data. The FDA issued a notice asking the company to address these vulnerabilities. About 195 units are affected.

The FDA identified potential cybersecurity issues with certain Edan iX series patient monitors (models iX10, iX12, iX15). These devices are used in hospitals and clinics to continuously monitor patients' vital signs. The affected units have specific serial numbers and manufacturing dates.

Edan Diagnostics received an FDA warning letter about potential cybersecurity issues affecting certain X-series patient monitors (models X8, X10, and X12) used in hospitals and clinics. These devices continuously monitor patient vital signs, and security vulnerabilities could potentially allow unauthorized access.

The FDA identified potential cybersecurity issues with Edan's iM20 patient monitor system, which is used in hospitals and during patient transport to track vital signs like heart rhythm, blood pressure, and oxygen levels. The company received an FDA letter about these vulnerabilities. No injuries have been reported.

The FDA identified potential cybersecurity issues in Edan Diagnostics patient monitors (elite V5, V6, and V8 models). These devices are used in hospitals and clinics to continuously monitor patient vital signs like heart rate, blood pressure, and oxygen levels. The company has been notified and is working to address the vulnerabilities.

Edan patient monitors (models iM50, iM60, iM70, and iM80) have potential cybersecurity vulnerabilities that could allow unauthorized access to the device. The FDA identified these issues and is requiring the manufacturer to address them. No injuries have been reported.

Edan Diagnostics recalled certain iM3s series vital signs monitors (models iM3s, iM3As, iM3Bs, iHM3s) due to potential cybersecurity issues identified by the FDA. These monitors measure patient vital signs in clinical settings. The recall affects 136 devices with specific serial numbers distributed across the U.S. and Mexico.

The FDA identified potential cybersecurity issues with Edan's iM3 vital signs monitor, a device used in hospitals and clinics to measure blood pressure, oxygen levels, heart rate, and temperature. The company has been notified and is working to address these vulnerabilities.

The FDA identified potential cybersecurity issues with certain Edan Model M3 Vital Signs Monitors used in healthcare settings. These portable devices measure blood pressure, oxygen levels, and temperature. The company received an FDA notice about the vulnerability.

Edan Diagnostics fetal and maternal monitors (models F6, F9, F6 Express, F9 Express) may have cybersecurity vulnerabilities that could potentially allow unauthorized access to the device. The FDA identified these issues and asked the company to address them. No injuries have been reported.

The FDA identified potential cybersecurity issues with Edan Diagnostics fetal and maternal monitors (models F2 and F3). These bedside monitors are used during pregnancy and labor to track the health of pregnant women and their fetuses. The manufacturer has been notified and is working with the FDA to address the vulnerabilities.

The body support strap on certain Rifton Equipment E-Pacer gait training devices (Model K660) may fray. Fraying could potentially affect the strap's function or safety during use. The company has identified specific serial numbers affected by this issue.

Rifton Equipment's Low Base TRAM powered lift device may have fraying on the body support strap used to secure clients during transfers. The fraying could potentially compromise the strap's ability to safely hold a person. This affects specific units manufactured between 2013 and 2015.

Rifton Equipment's TRAM powered lift device (Model K310) may have fraying on the body support strap. This strap is used to support clients during seated transfers or sit-to-stand training. Fraying could potentially affect the strap's integrity during use.

Sysmex America's TS-10/TS-10H Tube Sorter may experience an unexpected loss of electromagnetic holding force in the lift mechanism under certain conditions. This could cause the lift to move downward unintentionally. The issue affects 44 specific units identified by serial number.

Beckman Coulter's LDL Cholesterol OSR6x96 reagent may give inaccurate test results when patients have high triglyceride levels (above 1500 mg/dL). The test can overestimate LDL cholesterol by up to 29% in some samples, which could affect patient care decisions.

Intuitive Surgical has recalled certain Ion Vision Probe Bags (model 490127) because the sterile pouch seal may be compromised or incomplete. These bags are used to store the Vision Probe during lung biopsy procedures. A compromised seal could allow contamination of the sterile device.

MicroPort Orthopedics distributed a hip implant trial component (HIPTURN FEM HEAD TRIAL 36MM) in the United States without FDA premarket authorization. The company sent approximately 91 units to distributors across multiple states. No injuries have been reported.

Tyber Medical's VOLT wrist treatment system left distal radius plates (model 02.426.691S, lot 291293) were manufactured with incorrect thread orientation. This defect could affect proper plate positioning and screw fixation during wrist surgery. Approximately 64 units were distributed nationwide.

Tyber Medical's VOLT Wrist Treatment System left wrist plates (Model 02.426.681S, Lot 291294) were manufactured with incorrect thread orientation. This defect could affect proper plate installation during wrist surgery. No injuries have been reported.

Two Leaseir MHR Xcell surgical lasers used for hair removal and skin treatment were distributed with console labels missing the required "DANGER" symbol. The missing warning label could prevent users from recognizing laser hazard warnings. No injuries have been reported.

Merit Medical Systems is recalling certain Allwell Angioplasty Packs because the inflation device handle may detach from the syringe during a procedure. This could interrupt treatment and require the procedure to be stopped or repeated. No injuries have been reported.

Merit Medical Systems is recalling certain Custom Procedure Kits because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt the procedure or cause other complications. No injuries have been reported.

Merit Medical Systems is recalling its Custom Manifold Kit (model K09-13203A) because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt treatment or require procedure restart. No injuries have been reported.