🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Jul 2, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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Orascoptic Surgical Acuity
🏥 Medical Devices Class I - Dangerous
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Jul 24, 2025 Implants & Prosthetics Nationwide
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Jul 28, 2025 Infusion Pumps
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American Contract Systems
🏥 Medical Devices Class I - Dangerous
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Jul 14, 2025 Other Medical Devices
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🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025 Other Medical Devices Nationwide
View Details →