Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2)...
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.
Merit Medical , Custom Manifold Kit REF: K09-13203A
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.
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: Patient Monitor Model/Catalog Number: iM8, iM8A...
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.
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
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.
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/R...
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: Central Monitoring System Model/Catalog Number:...
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 Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-...
Inflation device handle may detach from the syringe during procedure.
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1070...
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.
SQ40S Blood Transfusion Filter
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 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.
MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2)...
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.
Patient Information Center iX; Software Version Number: 4.5.0
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF:...
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM6...
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.
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001100...
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.
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a po...
Potential for fraying on the body support strap.
Allwell Inflation Device, for angiographic use REF: IS-30-A
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.
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Ca...
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: ...
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: 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.
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Om...
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).