FDA-Device2026-01-14Class IIPROCESSING DEFECT
Philips Incisive CT scanner recalled for incomplete scans due to sensor connection issue
What this means
Philips Healthcare has recalled certain Incisive CT scanners due to an unstable internal connection in the floating sensor. This instability may cause the scanner to produce incomplete or compromised scans. The issue affects 35 devices distributed across the U.S. and its territories, and no injuries have been reported.
- Contact Philips Healthcare immediately if your facility operates an affected Incisive CT scanner
- Do not perform patient scans until you receive inspection or replacement guidance from Philips
- Check your device serial number against Philips' recall list to confirm if your unit is affected
The agency's original wording
Hazard
Potential for incomplete scan due to unstable connection inside of floating sensor.
Intended for
All ages
Illnesses reported
None reported
Sold states
U.S. and U.S. territories
Affected count
35
Manufactured in
Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, Suzhou, China
Products
Philips Incisive CT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2026Want us to check the next one for you?
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