February 26, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypo
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Softw
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1
Hazard: 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.
February 26, 2025Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0
Hazard: 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.
February 26, 2025Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 119
Hazard: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
February 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBA
Hazard: 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.
February 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP
Hazard: 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.
February 26, 2025Medical DevicesFDA
Hollister Incorporated recalls AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Hazard: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
February 26, 2025Medical DevicesFDA
Hollister Incorporated recalls AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Hazard: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
February 26, 2025Medical DevicesFDA
Hollister Incorporated recalls AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Hazard: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
February 26, 2025Medical DevicesFDA
Hollister Incorporated recalls AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Hazard: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
February 26, 2025Medical DevicesFDA
XTANT Medical Holdings, Inc recalls Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) an
Hazard: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
February 26, 2025Medical DevicesFDA
KCI USA, INC. recalls 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A
Hazard: Due to increase in complaints related to leak alarms
February 26, 2025Medical DevicesFDA
KCI USA, INC. recalls 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US P
Hazard: Due to increase in complaints related to leak alarms
February 26, 2025Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fl
Hazard: 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.
February 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Hazard: Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
February 26, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming
Hazard: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
February 26, 2025Medical DevicesFDA
Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming
Hazard: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.