Class I - Dangerous
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Stryker Medical Division of Stryker
Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Thor Photomedicine
Class I - Dangerous
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Integra LifeSciences
Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Stryker Medical Division of Stryker
Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Class I - Dangerous
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Thor Photomedicine
Class I - Dangerous
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Wilson-Cook Medical
Class I - Dangerous
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
Stryker Medical Division of Stryker
Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Class I - Dangerous
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Integra LifeSciences
Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Integra LifeSciences
Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Integra LifeSciences
Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Stryker Medical Division of Stryker
Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Stryker Medical Division of Stryker
Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
Thor Photomedicine
Class I - Dangerous
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
Stryker Medical Division of Stryker
Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Class I - Dangerous
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.