Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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.
Allura CV20; Catalog numbers: 722031
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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
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
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
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.
Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
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
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.
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
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.
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Augustine Temperature Management
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.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Possibility of the patient falling from the table related to the mattress used on the patient table.
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
XTANT Medical Holdings
Class I - Dangerous
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
RAYSEARCH LABORATORIES AB
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 Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Hollister Incorporated
Class I - Dangerous
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
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.