# Class II recall Z-0078-2027: PHILIPS MEDICAL SYSTEMS

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0078-2027 |
| Recalling firm | PHILIPS MEDICAL SYSTEMS |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Spectral CT and Spectral CT 7500 RT;  Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.);  Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.); |
| Reason | Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. |
| Quantity | 539 |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MD, MN, NC, NY, OH, PA, TX, VA, WV and the countries of Australia, Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, France, Germany, Hong Kong, India, Indones |
| Recall initiated | 2026-08-21 |
| Reported | 2026-10-14 |
| Firm location | Cambridge, MA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 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-0078-2027%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.