FDA Medical Device Recalls (openFDA)
Philips Healthcare (Suzhou) Co., Ltd.: Philips Incisive CT
- Recall number
- Z-1003-2026
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Product
- Philips Incisive CT
- Status
- Open, Classified
- Initiated
- 2025-12-03
- Posted
- 2026-01-08
- Terminated
- not on file
- Reason
- Potential for incomplete scan due to unstable connection inside of floating sensor.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install a hardware solution that will change the method of connection for the rear handle floating sensor. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-109 or FCO72800843.
- Quantity
- 35
- Distribution
- U.S. and U.S. territories
- Lot, serial or model codes
- N/A
- 510(k) numbers
- K180015, K212441
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3009529630
- Firm city
- Suzhou
- Firm state
- Pingjiang
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28