Medical device recalls

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.

Merit Medical Systems is recalling multiple Custom Inflation Kit models because the handle may detach from the syringe during use. This could interrupt a medical procedure. No injuries have been reported so far.

Merit Medical Systems is recalling specific lots of their Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt patient care. No injuries have been reported.

Merit Medical Systems is recalling the Allwell Inflation Device (model IS-30-A) used in angiographic procedures because the handle may detach from the syringe during use. This could compromise the procedure and patient safety. The recall affects specific lot numbers distributed worldwide.

Merit Medical Systems' basixCOMPAK inflation device handle may detach from the syringe during a medical procedure. This affects multiple reference numbers and lots of the 20 mL, 30 atm/bar model used in clinical settings.

Mazor Robotics has recalled its Mazor X robotic guidance system due to software errors in certain versions that could cause incorrect positioning of surgical instruments during spinal surgery. The affected software versions are 5.0.1, 5.1.2, and 5.1.3. About 549 systems worldwide are affected, and no injuries have been reported.

Baxter Healthcare has recalled certain SIGMA Spectrum infusion pumps (model 35700BAX2) because they may contain defective grease on internal gears. This defective grease does not lubricate properly, which can cause premature wear of the pump mechanism and lead to the pump delivering too much medication or allowing medication to flow freely without stopping.

ICU Medical's Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic line flush after piggyback therapy. In certain situations, the pump displays an error message that blocks the flush from being set up, even though the flush is a normal part of the treatment process.

ICU Medical's Plum Duo Precision IV Pump may prevent clinicians from programming an automatic flush after piggyback therapy in certain situations. When this happens, the pump displays an error message and the flush cannot be set up, which could affect how medications are delivered.

ICU Medical Plum Solo and Duo Infusion pumps have a software issue that may prevent clinicians from programming an automatic flush after piggyback therapy. When attempting to set up this flush feature, the pump may display an error message that blocks the programming, even though the flush itself is a safe feature.

Philips has identified two software issues in Azurion R3.1 systems that may cause the device to restart continuously, lose X-ray imaging capability, lose motorized movement, display incorrect images, or lose data. One issue affects all models; a second affects only systems with a Poly-G3 frontal stand.

Certain GE Healthcare Omni Legend PET scanners may occasionally produce streaking artifacts in scan images. This visual distortion appears as lines in the images displayed on the scanner console and could affect image quality used for clinical diagnosis.

ICU Medical's Tego Connector needle-free access devices have a silicone seal that may bulge, separate, or tear. This defect can cause fluid leaks, blockages, inability to draw or inject medication, and potential exposure to contamination or air in the bloodstream during hemodialysis or IV therapy.