Failure Risk Prompts Recall of Samaritan 300/300P Defibrillators
Samaritan 300/300P PAD public access defibrillators are being recalled by HeartSine technologies due to a possible failure issue that could lead to a delay in a person getting needed therapy for cardiac arreast. The issues associated with the devices are twofold: first, the items can randomly turn on and off, a condition that may deplete… read more
OASYS Midline Occiput Plate Spinal Implants Recalled Over Injury Risk
Stryker has announced the recall of the OASYS Midline Occiput plate spinal implant due to concerns about the possibility of patient adversity. The pin that keeps the plate body and the tulip head of the devices connected is apparently in danger of suffering a fracture. When this occurs, it can do damage to the patient’s… read more
Infusion Systems Recalled By Iradimed Due To Possible Injury Hazard
A risk of improper infusion has prompted the recall of an infusion pump designed to be used in conjunction with an MRI scan. The recall was announced by the Iradimed Corporation and affects MRidium 3860+ Infusion Systems that contain an 1145 Dose Error Reduction System Drug Library Kit. When a healthcare professional is setting the… read more
LPS Lower Extremity Dovetail Device Recalled By DePuy Over Safety Risk
DePuy Orthopaedics has announced the recall of LPS Lower Extremity Dovetail Intercalary Components because of an issue that could lead to pain or even a revision procedure. The device, which is implanted in patients requiring a partial or total femur replacement or a proximal tibia replacement, can experience a fracture along the female portion of… read more
Parents Asked By FDA To Report Children’s Medical Device Defects
Children’s medical devices have become increasingly commonplace, but the Food and Drug Administration is concerned that parents might not be adequately prepared to report potential adversity associated with a product. Many parents may find themselves attributing a side effect or some type of error to the child or something that they have done wrong, but… read more
V60 Ventilators Recalled By Respironics California Over Injury Risk
V60 ventilators are being recalled by Respironics California because of a potential software issue that could compromise patient safety. The items were made available across the country between November 16, 2009 and March 28 of this year. The Power Management Board Assembly, if it experiences a component failure, may lead to support being taken away… read more
FDA Explains What Hospitals Can Do to Boost Medical Device Security
Last week, we explained the Food and Drug Administration’s stance on the cyber security of medical devices. But with a report to Congress on the dangers of hacking now in, the agency is attempting to get device makers and hospital administrators alike to do what they can to ensure safety. The FDA points out that… read more
FDA Concerned About Medical Device Hacking
As medical devices become more and more complex, they also may become open to hackers looking to gain access to the device. Such is the fear of the Food and Drug Administration, which has just released a report to Congress seeking to stress the importance of cyber security. In particular, the FDA worries that oversights… read more
FDA Developing Framework For Medical App Regulation
The burgeoning nature of the medical app industry is something that no one could have predicted ten years ago. As more and more hospitals and doctors across the country begin to adopt apps for a variety of purposes, the Food and Drug Administration is trying to come to terms with these new innovations and develop… read more
FDA Offers New MedWatch Form to Patients
Have you ever been so worried about the side effects of a medical product that you’ve filed an adversity report with the Food and Drug Administration’s MedWatch program? If not, don’t worry, because you’re not alone. For many, the thought never even crosses their minds, and some think the process of filing an adversity report… read more
Debate Continues Over Da Vinci Surgical System’s Safety
Robots are being used in hospitals more frequently, but as a new report shows us, there’s likely going to be quite a bit of litigation before the technology is widely accepted. Sparking a debate over the safety of such technology is the Da Vinci Surgical System from the Sunnyvale, California-based Intuitive Surgical. Although the machine… read more
Da Vinci Maker Warns About Potential for Inadvertent Burns
Recently, Intuitive Surgical issued a warning about their da Vinci Surgical System, a device that has seen its share of complaints from those who allege the product led them to experience complications during surgery. The scissors of the system have a shaft whose distal end is in danger of suffering microcracks. When this occurs, energy… read more
