CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Spectral CT on Rails recalled by Philips Medical Systems
Philips Medical Systems is recalling Spectral CT on Rails, distributed nationwide in the US. The recall was initiated on 13 Dec 2023 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-1054-2024
- FDA event ID
- 93798
- Recalling firm
- Philips Medical Systems, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Dec 2023
- FDA classified
- 8 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Medical Software
Timeline
| 13 Dec 2023 | Recall initiated by company | |
| 8 Feb 2024 | Classified by FDA | +57 days |
| 14 Feb 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Product as listed by the FDA
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Where it was distributed
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.
Nationwide ArkansasArizonaGeorgiaHawaiiIndianaKentuckyMassachusettsMarylandMinnesotaNew YorkOhioPennsylvaniaTexasWest Virginia
Questions about this recall
Why was it recalled?
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Which lots are affected?
UDI-DI: 00884838103627, serial number: 1005.
Where was it sold?
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.
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.
Other products in this recall event
1 other product · FDA event 93798This product is part of a recall event; the main page for the event is Spectral CT recalled by Philips Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Spectral CT recalled by Philips Medical Systems | Philips Medical Systems | Labeling Errors | Nationwide |
More recalls from Philips Medical Systems
All 82| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | IQon Spectral CT IQon Spectral CT Upgrades recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Spectral CT on Rails recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
Other Medical Software recalls
All 932| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |