Philips North America Llc: Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Philips North America Llc
- Product
- Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. and U.S. Territories.
- Recall initiated
- 2026-08-18
- Code info
- UDI: (01)00884838101111
- Product quantity
- 62
- Voluntary mandated
- FDA Mandated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 99865
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