- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Reason for recall
- The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. 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.
- Affected products (lot / model / serial)
- FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
- Units affected
- 128
- Distribution pattern
- US Nationwide Distribution including Puerto Rico
- Firm location
- Cambridge, MA, United States
- Recall type
- FDA Mandated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2650-2026
- Recall initiated
- June 11, 2026
- FDA classification date
- July 27, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99352
- Last updated on HTM Vibe
- August 11, 2026