Philips Spectral CT on Rails — Class II medical device recall Z-1825-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS, reported 2026-04-22, distributed nationwide. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential tha
| Recall number | Z-1825-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS, Cambridge, MA, United States |
| Recall initiated | 2026-03-07 |
| Classified | 2026-04-16 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, NL |
| Quantity | 3 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838103627 |
| Serial numbers | 1005, 1006, 1007 |
| Model numbers | 728334 |
Product
Philips Spectral CT on Rails. Model Number: 728334.
Reason for recall
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1825-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.