Philips Medical Systems Technologies Ltd. Spectral CT 7500 recall (Philips North America Llc)
Medical deviceClass IIOngoing
Summary: Philips North America Llc is recalling Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333. Reason: 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.
What is being recalled
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. and U.S. Territories.
How to tell if yours is affected
UDI: (01)00884838101111
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3155-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 18, 2026 |
| Reported | October 7, 2026 |
| Company | Philips North America Llc |
| Company location | Cambridge, MA, United States |
| Initiated by | FDA Mandated |
| Quantity | 62 |
More recalls from Philips North America Llc · all medical device recalls · recalls from August 2026