Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Rad...
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 P...
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.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s,...
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.
Philips Azurion system; Software Version Number: R3.1;
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, ...
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.
Allwell Angioplasty Pack REF: IS-30-B1/B
Inflation device handle may detach from the syringe during procedure.
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a un...
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lif...
Potential for fraying on the body support strap.
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3....
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample t...
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model...
Due to products not having FDA Premarket authorization to be distributed within the United States.
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Pro...
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.
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956...
Inflation device handle may detach from the syringe during procedure.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: ...
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Inflation device handle may detach from the syringe during procedure.
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: ...
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Soft...
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 ...
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.
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait...
Potential for fraying on the body support strap.
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003...
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B ...
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.
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.