Class II — PHILIPS MEDICAL SYSTEMS
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. |
| Product | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. |
| Quantity | US: 1 |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom. |
| Initiated | 2023-12-13 |
| Classified | 2024-02-08 |
| Recall number | Z-1054-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PHILIPS MEDICAL SYSTEMS (Z-1054-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93798/
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