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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Gold Star Distribution Inc is recalling Pregnancy Test 24CT units due to potential rodent exposure and rodent activity in the distribution center. The product was distributed in Minnesota.
Canon Medical's Alphenix INFX-8000V x-ray systems may have loose ceiling movement gear screws, risking loss of ceiling lateral movement, abnormal noise, and sensor errors across 332 units worldwide.
Gold Star Distribution Inc is recalling First Aid Kit 24/42PC and Lucky First Aid Bandages 24CT due to potential rodent exposure in the distribution center. Products were distributed in Minnesota.
Philips recalled five Ingenia Elition S MR systems with software versions R11.1 and R12.1 due to potential stiffness value calculation errors. The issue affects elastography data displayed in PACS viewers worldwide.
Zimmer Surgical is recalling 51 A.T.S. 3200TS Tourniquet Systems because the device screen may freeze or become unresponsive when operating in non-English language settings. Affected units distributed to Canada and EMEA.
Medline is recalling 13,245 Semi Electric Lightweight Homecare Beds because hand control pendants may overheat and pose a fire risk in certain conditions. The company has received 58 reports of pendant sparking, burning, melting, smoking, or fire.
Medline is recalling 373,392 Semi Electric Basic Homecare Beds due to hand control pendants that may overheat and pose a fire risk. The company has received 58 complaints of pendant sparking, burning, melting, and smoking.
Medline Industries is recalling Full Electric Lightweight Homecare Beds due to a fire hazard in the hand control pendant. The pendant may overheat under certain operating conditions and pose a risk of fire.
Medline is recalling Full Electric Basic Homecare Beds because the hand control pendant may overheat and catch fire in rare scenarios. The company has received 58 complaints of pendant sparking, burning, melting, or fire.
Medline Industries recalls homecare beds due to fire risk in the hand control pendant. The pendant may overheat and ignite, posing a fire hazard to users.
Medline is recalling Full Electric Low Basic Homecare Beds due to a fire hazard in the hand control pendant. The pendant may overheat under certain operating conditions, creating a risk of fire.
ICU Medical Plum Duo infusion pumps have a software issue preventing clinicians from programming the automatic flush feature after piggyback therapy, affecting this critical safety function.
ICU Medical Plum Solo Precision IV pumps may display error messages preventing clinicians from programming the automatic downstream line flush after piggyback therapy.
RayStation/RayPlan radiation therapy treatment planning software contains a defect where dose calculation invalidation may fail for certain treatment areas, potentially affecting treatment planning accuracy.
Merit Medical is recalling Custom Manifold Kits (REF: K09-13203A) due to a hazard where the inflation device handle may detach from the syringe during procedures. Approximately 2,192 units were distributed worldwide.
Rifton E-Pacer gait training devices (Model K660) are being recalled because their body support straps may fray during use. This could affect patients' safety during gait training activities.
Tyber Medical is recalling 64 units of VOLT Wrist Treatment System orthopedic plates due to incorrect thread orientation that may affect proper device fixation during surgical repair.
RayStation radiation therapy software versions 11.0.0-11.0.4 fails to recalculate doses when certain regions of interest are modified. The dose invalidation function does not work properly for ROIs without contours that have material overrides or are type Bolus, Fixation, or Support.
EDAN Vital Signs Monitor iM3 models are being recalled due to potential cybersecurity vulnerabilities identified in an FDA letter. Approximately 11,987 units were distributed nationwide and in Mexico.
The Leaseir MHR Xcell surgical laser is missing a required 'DANGER' symbol on its console label. This labeling deficiency may prevent operators from being adequately warned of the device's hazards.
Certain SIGMA Spectrum Infusion Pumps (Model 35700BAX2) contain defective grease on internal gears that may cause insufficient lubrication, leading to premature wear and potential over-infusion or free-flow. Baxter is recalling 585 units distributed nationwide.
Merit Medical is recalling 18,897 Custom Inflation Kits because the inflation device handle may detach from the syringe during use, potentially affecting device function.
RayStation radiation therapy planning software version 10B SP1 has a defect where dose calculations fail to invalidate properly when certain regions of interest are modified, potentially affecting treatment planning accuracy.
EDAN vital signs monitors (iM3s series) are being recalled due to potential cybersecurity issues identified by the FDA. Approximately 136 units distributed nationwide and in Mexico are affected.
Merit Medical custom procedure kits contain inflation devices whose handles may detach from the syringe during medical procedures, potentially compromising procedure execution.
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