CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Philips Incisive CT recalled by Philips Healthcare (Suzhou) Co
Philips Healthcare (Suzhou) is recalling Philips Incisive CT, distributed nationwide in the US. The recall was initiated on 26 Jun 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-2988-2026
- FDA event ID
- 99511
- Recalling firm
- Philips Healthcare (Suzhou), Suzhou, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2026
- FDA classified
- 21 Aug 2026
- Reported
- 2 Sep 2026
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 26 Jun 2026 | Recall initiated by company | |
| 21 Aug 2026 | Classified by FDA | +56 days |
| 2 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential of failing to trigger clinical scan during Bolus Tracking.
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 Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Where it was distributed
U.S. Nationwide and U.S. Territories distribution.
Questions about this recall
Why was it recalled?
Potential of failing to trigger clinical scan during Bolus Tracking.
Which lots are affected?
Device Identifier: (01)00884838085015, (01)00884838105508.
Where was it sold?
U.S. Nationwide and U.S. Territories distribution.
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.
More recalls from Philips Healthcare (Suzhou)
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Incisive CT recalled by Philips Healthcare (Suzhou) Co | Philips Healthcare (Suzhou) | Device Malfunction | |
| Device | CLASS II | Incisive CT recalled by Philips Healthcare (Suzhou) Co | Philips Healthcare (Suzhou) | Device Malfunction | Nationwide |
| Device | CLASS II | Philips CT systems are advanced continuous-rotation recalled | Philips Healthcare (Suzhou) | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| 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 |