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aja38 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years, 4 months ago
The DORO Lucent Headrest System has been recalled. It is supposed to support the head and neck during brain or spinal surgeries while the patient being still. However, DORO® LUCENT Base Unit, Locking Transitional Member, and Transitional Member were fitting properly which could cause harm and even death because during surgery one slip cut in the brain or spinal cord due to the inaccuracy of the system can paralysis or kill the patient. Pro-Med Instrument has recalled the system, but the FDA has classified it as a Class 1 recall. The reason it is class 1 because it can kill patients. I don’t think FDA is responsible because they didn’t initiate recall.