FDA Expands Philips CT Scanner Recall to Include Additional Software Versions
Philips North America expands its recall of certain CT scanners due to an unintended radiation issue, now covering additional software versions.
5 reports on this incident · first at Sep 3, 2026, 4:46 p.m. ET
Earlier reports
Sep 3, 2026, 5:27 p.m. ET
FDA Reclassifies Philips CT Scanner Recall as Class 2
The U.S. Food and Drug Administration has reclassified the recall of certain Philips computed tomography scanners as Class 2, according to an FDA enforcement report published September 3, 2026. The recall, initiated August 7, 2026, covers Philips IQon Spectral CT, Brilliance iCT, Ingenuity CT, and Brilliance CT 64 scanners with software version 4.1.10.x, distributed in the United States and its territories. The agency cited an unintended radiation issue that could affect how the equipment performs. No patient injuries are described in the recall records.
Class 2 is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote, according to the FDA's recall definitions. The remedy is to update the software free of charge. The recall numbers are Z-3040-2026, Z-3041-2026, Z-3042-2026, and Z-3043-2026. The FDA database records no other enforcement action by this firm.
Sep 3, 2026, 5:23 p.m. ET
FDA Reports Injuries in Philips CT Scanner Recall
The U.S. Food and Drug Administration (FDA) has reported injuries in connection with the recall of certain Philips computed tomography (CT) scanners, according to an enforcement report published September 3, 2026. The agency did not specify the nature or number of injuries, and the recall records do not describe any patient injuries.
The recall, initiated August 7, 2026, covers Philips IQon Spectral CT, Brilliance iCT, Ingenuity CT, and Brilliance CT 64 scanners with software version 4.1.10.x. The FDA classified the action as Class II, its middle category, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The agency said the issue involves an unintended radiation problem that could affect equipment performance.
Philips North America is offering a free software update to address the issue. The recall is listed as open and affects the United States and its territories. The FDA's database records no other enforcement actions by this firm.
Sep 3, 2026, 4:54 p.m. ET
FDA Closes Recall of Philips CT Scanners Over Radiation Issue
The U.S. Food and Drug Administration has closed the recall of certain Philips computed tomography scanners that was initiated on August 7, 2026, over an unintended radiation issue that could affect how the equipment performs. The agency considers the recall carried out, according to the FDA enforcement report.
The recall covers Philips IQon Spectral CT, Brilliance iCT, Ingenuity CT, and Brilliance CT 64 scanners with software version 4.1.10.x, distributed in the United States and its territories. The recall numbers are Z-3040-2026, Z-3041-2026, Z-3042-2026, and Z-3043-2026. The remedy was to update the software free of charge. No patient injuries are described in the recall records.
The FDA classified the action as Class 2, its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The recall was reported by Medical Daily. The FDA database records no other enforcement action by this firm.
Sep 3, 2026, 4:46 p.m. ETFirst report
Philips Recalls CT Scanners Over Radiation Issue; FDA Classifies as Class 2
Philips North America has initiated a recall of certain computed tomography (CT) scanners due to an unintended radiation issue that could affect how the equipment performs, according to a report from Medical Daily. The recall, which began on August 7, 2026, affects Philips IQon Spectral CT, Brilliance iCT, Ingenuity CT, and Brilliance CT 64 scanners with software version 4.1.10.x, distributed in the United States and its territories. The FDA has classified this as a Class 2 recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote, according to the FDA's recall definitions.
The recall numbers are Z-3040-2026, Z-3041-2026, Z-3042-2026, and Z-3043-2026, as listed in the FDA enforcement report. The remedy is a free software update. No patient injuries are described in the recall records, and the recall status is open. The FDA's enforcement database records no other enforcement action by this firm, according to the same report.
CT scanners are electromechanical systems that use X-rays to create cross-sectional digital images, typically sold as large-scale capital hardware to institutional buyers, according to reference sources. The recall was reported on September 3, 2026.
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Sources
- Four Philips CT Scanner Recalls Now Cover an Unintended Radiation Issue Affecting Hospitals Across the United Statesmedicaldaily.com
- https://api.fda.gov/food/enforcement.json?search=recall_number:%22Z-3040-2026%2C%20Z-3041-2026%2C%20Z-3042-2026%2C%20and%20Z-3043-2026%22
- https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
Revision history
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