RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Potential for reported SSD to be too high.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
IVOCLAR VIVADENT AG
Class I - Dangerous
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Potential for reported SSD to be too high.
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Cardinal Health 200
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Potential for reported SSD to be too high.
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Potential for reported SSD to be too high.
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Cardinal Health 200
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
IVOCLAR VIVADENT AG
Class I - Dangerous
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Potential for reported SSD to be too high.
Class I - Dangerous
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
Potential interference with the anti-fall system.