Suzhou, N/A, China
Philips Healthcare (Suzhou) Co., Ltd. recalls
4 recalls recorded since 2018, most recently on 26 June 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 June 2026
- Reason
- Potential of failing to trigger clinical scan during Bolus Tracking.
- Distribution
- U.S. Nationwide and U.S. Territories distribution.
- Initiated
- FDA Mandated
- Recall number
- Z-2988-2026
- Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Ongoing Class II Medical devices
- Recall started
- 3 December 2025
- Reason
- Potential for incomplete scan due to unstable connection inside of floating sensor.
- Distribution
- U.S. and U.S. territories
- Initiated
- FDA Mandated
- Recall number
- Z-1003-2026
Ongoing Class II Medical devices
- Recall started
- 23 December 2022
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Bhutan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0640-2024
- Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Terminated Class II Medical devices
- Recall started
- 24 February 2021
- Terminated
- 17 February 2023
- Reason
- Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekist
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1273-2021
- Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.