CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
Spectral CT on Rails recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Spectral CT on Rails, distributed in Minnesota. The recall was initiated on 28 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1324-2025
- FDA event ID
- 96423
- Recalling firm
- Philips Medical Systems Nederl, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2025
- FDA classified
- 12 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 28 Feb 2025 | Recall initiated by company | |
| 12 Mar 2025 | Classified by FDA | +12 days |
| 19 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Where it was distributed
Domestic: MN
Questions about this recall
Why was it recalled?
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Which lots are affected?
Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;
Where was it sold?
Domestic: MN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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