FDA Enforcement Records Detail Class II Recall of Philips CT Scanners
The ongoing recall covers 42 IQon Spectral CT units and upgrades distributed across the United States and Puerto Rico.
2 reports on this incident · first at Aug 20, 2026, 8:20 a.m. ET
Earlier reports
Aug 20, 2026, 8:20 a.m. ETFirst report
FDA Classifies Philips Medical Systems CT Scanner Recall as Class II
On August 5, 2026, official FDA documentation detailed an ongoing Class II medical device recall initiated on June 11, 2026, by Cambridge-based Philips Medical Systems. The FDA defines Class II as its middle category, used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The action is developing and remains ongoing.
The recall covers 42 units of IQon Spectral CT and IQon Spectral CT Upgrades. Distributed nationwide across the United States including Puerto Rico, the recalled devices carry identifying codes FCO72800812, FCO72800814 728331 728332, and DI (01)00884838059542 under recall number Z-2651-2026.
According to the FDA enforcement report, the clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually, and additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. The agency's database lists no other enforcement action for this firm.
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- Version 120 Aug 2026, 12:20current
First published.
- Version 120 Aug 2026, 12:22current
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