🏥 Medical Devices Class I - Dangerous
Due to increase in complaints related to leak alarms
All Recalls
92,900 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
🏥 Medical Devices Class I - Dangerous
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
🏥 Medical Devices Class I - Dangerous
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
🏥 Medical Devices Class I - Dangerous
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Due to increase in complaints related to leak alarms
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
🏥 Medical Devices Class I - Dangerous
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Allura CV20; Catalog numbers: 722031
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Hollister Incorporated
🏥 Medical Devices Class I - Dangerous
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Hollister Incorporated
🏥 Medical Devices Class I - Dangerous
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Augustine Temperature Management
🏥 Medical Devices Class I - Dangerous
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.