In a recent development concerning patient safety, Philips, a prominent medical technology company, has initiated a voluntary recall of its nuclear imaging system, the BrightView SPECT (single-photon emission computed tomography). This recall, highlighted by the U.S. Food and Drug Administration (FDA), comes in response to potential safety risks associated with the device. Specifically, the recall addresses concerns regarding the system’s detector, which may experience downward movement due to screw failure, posing a risk of injury to patients. Classified as a Class I recall by federal authorities, the most severe classification by the FDA, this action underscores the potential for “serious adverse health consequences or death” resulting from the device malfunction.
The FDA’s notice emphasizes the range of potential injuries patients may face if the detector malfunctions, including abrasions, contusions, lacerations, and fractures to lower limbs. Additionally, system operation may be interrupted, further complicating patient care. While there have been no reported instances of patient harm thus far, the recall serves as a proactive measure to mitigate potential risks to individuals undergoing nuclear imaging procedures.
Philips promptly initiated communication with customers upon identifying the issue, issuing a field safety notice in December to raise awareness among users. The recall stems from a single complaint received by the company during routine surveillance activities, indicating a commitment to vigilant monitoring of product performance and patient safety. As part of the recall process, Philips is coordinating inspections of affected systems, implementing additional safety measures, and facilitating necessary replacements to address the identified concerns.
Despite discontinuing production and sales of the BrightView SPECT family of products in 2014, Philips remains dedicated to addressing safety issues associated with existing systems still in use. The recall affects approximately 1,000 imaging systems worldwide, prompting regulatory agencies beyond the U.S., such as the Australian Therapeutic Goods Administration, to issue corresponding recall notices.
In response to the recall, healthcare providers are advised to refrain from positioning patients’ lower limbs directly under the detector, particularly below the center of the gantry bore, to minimize potential risks. Furthermore, dissemination of the safety notice to all device users is encouraged, with instructions to keep the communication readily accessible near impacted imaging systems until corrective measures are completed.
Individuals with inquiries or concerns regarding the recall are encouraged to contact Philips’ customer care solutions center for assistance and guidance. This proactive approach underscores Philips’ commitment to prioritizing patient safety and underscores the importance of prompt action to address potential risks associated with medical devices.
In the unfortunate event that individuals experience harm or injury due to the malfunction of the BrightView SPECT system, pursuing legal recourse may be necessary to seek compensation for damages incurred. Victims of product-related injuries may have grounds to file a lawsuit against Philips, holding the company accountable for the resulting harm. Legal action in product liability cases involving defective medical devices typically involves several key steps.
Firstly, individuals must consult with a qualified attorney specializing in product liability claims to assess the merits of their case and determine the appropriate legal strategy. An experienced attorney can provide invaluable guidance throughout the litigation process, advocating for the rights of the injured party and navigating complex legal proceedings.
Upon initiating a lawsuit, the legal team will gather evidence to establish liability, demonstrating how the defect in the BrightView SPECT system contributed to the plaintiff’s injuries. This may involve expert testimony, medical records, and documentation of the device’s design flaws or manufacturing defects.
Throughout the litigation process, skilled attorneys will negotiate with the defendant, seeking fair compensation for damages such as medical expenses, lost wages, pain and suffering, and other losses incurred as a result of the injury. In cases involving severe injuries or wrongful death, substantial damages may be awarded to compensate victims and their families for the profound impact of the harm suffered.
Ultimately, securing the services of a reputable product injury law firm such as Parker Waichman LLP is essential for navigating the complexities of product liability lawsuits and maximizing the chances of a favorable outcome. With a proven track record of success in handling medical device injury cases, Parker Waichman LLP offers experienced legal representation and compassionate support to victims seeking justice and fair compensation.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
If you or a loved one has been injured due to the malfunction of a Philips nuclear imaging system or any defective medical device, don’t hesitate to take action. Contact Parker Waichman LLP today for a free consultation by calling 1-800-YOUR-LAWYER (1-800-968-7529) and learn more about your legal rights and options. Let us fight for the justice and compensation you deserve.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.
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