RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
All Recalls
95,018 total recalls in our database
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
Johnson & Johnson Surgical Vision
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
🏥 Medical Devices Class I - Dangerous
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
🏥 Medical Devices Class I - Dangerous
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
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
🏥 Medical Devices 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
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Cardinal Health 200
🏥 Medical Devices 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.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Potential for reported SSD to be too high.
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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