Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Philips Incisive CT
Why it was recalled
Potential for incomplete scan due to unstable connection inside of floating sensor.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. and U.S. territories
Recall record
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Product type
- Devices
- Recall number
- Z-1003-2026
- Voluntary / mandated
- FDA Mandated
- Origin
- Suzhou
- Recall initiated
- 2025-12-03
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1003-2026 · Source: openFDA enforcement.