FDAFDA recall Z-3155-2026 · Oct 7, 2026
Philips North America Llc: Philips Medical Systems Technologies Ltd recall
Recall found
Product
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: (01)00884838101111
- Quantity
- 62
- Distribution
- U.S. and U.S. Territories.
- Recalling firm
- Philips North America Llc, Cambridge, MA
- Voluntary or mandated
- FDA Mandated
- Recall started
- 2026-08-18
Source: openFDA enforcement record Z-3155-2026 · search recall number Z-3155-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.