# Class II recall Z-3155-2026: Philips North America Llc

**Predicate Speed & CAPA Advisory Opportunity Score:** 70/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3155-2026 |
| Recalling firm | Philips North America Llc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | FDA Mandated |
| Specialty | Other |
| Product | 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. |
| Quantity | 62 |
| Distribution | U.S. and U.S. Territories. |
| Recall initiated | 2026-08-18 |
| Reported | 2026-10-07 |
| Firm location | Cambridge, MA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- FDA-mandated rather than firm-initiated.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3155-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.