- Recalling firm
- Philips North America Llc
- Reason for recall
- The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
- Affected products (lot / model / serial)
- UDI: (01)00884838101111
- Units affected
- 62
- Distribution pattern
- U.S. and U.S. Territories.
- Firm location
- Cambridge, MA, United States
- Recall type
- FDA Mandated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3155-2026
- Recall initiated
- August 18, 2026
- FDA classification date
- September 29, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99865
- Last updated on HTM Vibe
- October 13, 2026
