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.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
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.
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
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.
Allura Xper FD20/15; Catalog numbers: 722058
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.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (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.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
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.
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
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.
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (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.
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Hollister Incorporated
Class I - Dangerous
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (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.
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
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, 89 cm (35"), REF US530, 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 FD20/10; Catalog numbers: 722029
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 FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
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 FD10C; Catalog number: 722001
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.
Cardio Vascular-Allura Centron; Catalog number: 722400 (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.