FDA объявила о четырех отзывах сканеров Philips из-за непреднамеренной проблемы с дозой облучения

Four Philips CT Scanner Recalls Now Cover an Unintended Radiation Issue Affecting Hospitals Across the United States Federal regulators have posted four separate recall records covering Philips computed tomography scanners after the manufacturer identified what it describes as an unintended radiation issue that could affect how the equipment performs. All four records were classified by the Food and Drug Administration as Class 2 and posted on Sept. 1. The affected systems are among the most widely installed CT platforms in American hospitals. The records name the Philips IQon Spectral CT, the Brilliance iCT family, Ingenuity CT, and Brilliance CT 64. Philips initiated the action on Aug. 7, and distribution covers the United States and its territories. For patients, this is not a reason to cancel imaging. It is a reason to understand what a Class 2 designation means and what a hospital is supposed to do about it, because the fix is a free software update that Philips is scheduling with customers rather than a removal of machines from service. Four Records, One Software Problem The four recall numbers are Z-3040-2026, Z-3041-2026, Z-3042-2026, and Z-3043-2026, all filed under the same recall event. Splitting a single manufacturer action across multiple records by product line is routine in the FDA device recall database, and it means anyone reading only one record sees a fraction of the affected equipment. Each record lists the specific software versions covered. The Brilliance iCT entry, which is representative of the set, covers Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP systems running software version 4.1.10.x, and lists the recalling firm as Philips North America in Cambridge, Massachusetts. The manufacturer's stated reason is identical across all four entries. FDA recorded the determined cause under the Radiation Control for Health and Safety Act, the federal statute governing radiation-emitting electronic products. Philips is notifying customers through an Electronic Product Radiation Correction notification dated August and will schedule appointments with remaining customers to update the software free of charge. The company reference number is 2025-PD-CTAMI-014, and Philips directs facilities to its customer care line listed in the records. All four records remain listed as open, meaning the manufacturer has begun the correction and not all affected units have been addressed yet. The records do not list a quantity in commerce, so the number of installed systems affected in the United States is not stated publicly. FDA explains the classification process and what each tier means in its overview of medical device recalls. Patients Scheduled for Scans This Week A Class 2 recall is defined by FDA as a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. It is the middle tier of three. It is not the category reserved for products with a reasonable probability of serious injury or death. No patient injuries are described in the recall records. The action is a correction, not a removal, and the systems are not being pulled from hospitals. Radiology departments continue scanning while software updates are scheduled. That distinction matters because delaying a medically indicated CT scan carries its own risk. A scan ordered to rule out a stroke, a pulmonary embolism, appendicitis or internal bleeding is answering a time sensitive question. The clinical cost of postponing that answer is generally far larger than the incremental risk described here. Patients who want to ask something useful can ask whether their imaging department has already applied the correction, and whether the specific scanner being used is one of the four named product lines. Most hospitals operate scanners from multiple manufacturers and generations. Radiation Dose in Context CT delivers meaningfully more ionizing radiation than a standard X-ray, which is why dose management has been an active area of regulation and hospital quality work for two decades. The standing principle is that each scan should be clinically justified and performed at the lowest dose consistent with a usable image. Populations with the most at stake from cumulative dose are children, patients who undergo repeat imaging for chronic conditions or cancer surveillance, and pregnant patients. For these groups, the standing recommendation predates this recall. Ask whether an alternative without ionizing radiation, such as ultrasound or magnetic resonance imaging, would answer the same clinical question. The recall records do not quantify the magnitude of the radiation deviation, state a direction, or describe any patient harm. Those details are not in the public entries. Anyone reporting a specific dose figure is going beyond what FDA has published. Questions Worth Asking the Imaging Desk Hospital biomedical engineering and radiology leadership are the parties who act on this. Facilities that have not been contacted can reach Philips through its customer care line listed in the recall records. Patients undergoing frequent CT surveillance can ask their physician whether the imaging interval is still appropriate, whether prior images can answer the current question, and whether the facility tracks cumulative dose across studies. Several health systems now record this automatically. Anyone who has already had a scan on one of these systems does not have a documented injury to act on. FDA has not issued patient notification guidance, and the records describe an equipment performance issue rather than confirmed patient harm. Hospitals have absorbed a run of equipment and supply problems this year, including a recall of intravenous fluid bags over particulate contamination. The situation may develop. Recall classifications can be updated, and FDA notes that cause determinations remain subject to modification until a recall is terminated. Readers should watch the agency's device recall database rather than relying on a single record found through a search engine, because as this event shows, one record can miss three others. Key Questions Answered Which scanners are affected? Philips IQon Spectral CT, Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP, Ingenuity CT and its listed variants, and Brilliance CT 64 systems, each at specific software versions listed in the FDA records. What is the problem? Philips identified an unintended radiation issue that could affect equipment performance. The FDA logged the determined cause under the Radiation Control for Health and Safety Act. The public records do not quantify the deviation. Is this a Class 1 recall? No. All four records are Class 2, the middle severity tier, used when a product may cause temporary or medically reversible health consequences or where serious harm is remote. Are scanners being removed from hospitals? No. This is a correction. Philips is notifying customers and scheduling free software updates. Imaging departments continue operating during that process. Should a scheduled CT scan be canceled? Delaying a medically indicated CT carries its own risk, often larger than the issue described here. Discuss any concern with the ordering physician rather than canceling independently. Who faces the most cumulative radiation risk? Children, patients undergoing repeat imaging for chronic disease or cancer surveillance, and pregnant patients. For these groups, it is reasonable to ask whether ultrasound or MRI could answer the same question. How can a hospital confirm its status? Through Philips customer care using the reference listed in the FDA recall records, and through the facility's biomedical engineering department, which tracks field correction notices. Published by Medicaldaily.com