Philips Healthcare (Suzhou) Co., Ltd. Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class II
December 3, 2025
Philips Incisive CT
Potential for incomplete scan due to unstable connection inside of floating sensor.
- Class II
December 23, 2022
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
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