CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Philips Medical Systems Technologies Ltd recalled
Philips North America is recalling Philips Medical Systems Technologies Ltd. The recall was initiated on 18 Aug 2026 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-3155-2026
- FDA event ID
- 99865
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2026
- FDA classified
- 29 Sep 2026
- Reported
- 7 Oct 2026
- Type
- FDA Mandated
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 18 Aug 2026 | Recall initiated by company | |
| 29 Sep 2026 | Classified by FDA | +42 days |
| 7 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
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
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Where it was distributed
U.S. and U.S. Territories.
Questions about this recall
Why was it recalled?
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Which lots are affected?
UDI: (01)00884838101111
Where was it sold?
U.S. and U.S. Territories.
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 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips North America
All 558| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Ambition S and Ingenia Ambition recalled | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
Other Medical Software recalls
All 930| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Tandem t:slim mobile application t:slim Mobile Application, iOS recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |