FDA recall Z-1003-2026
Philips Healthcare (Suzhou) Co., Ltd. · Class II · device
Product
Philips Incisive CT
Reason for recall
Potential for incomplete scan due to unstable connection inside of floating sensor.
Distribution
U.S. and U.S. territories
Key facts
- Status
- Ongoing
- Initiation date
- 2025-12-03
- Report date
- 2026-01-14
- Voluntary/Mandated
- FDA Mandated
- Location
- Suzhou, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2026