FDA Medical Device Recalls (openFDA)
Philips Healthcare (Suzhou) Co., Ltd.: Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Recall number
- Z-2988-2026
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Product
- Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Status
- Open, Classified
- Initiated
- 2026-06-26
- Posted
- 2026-08-21
- Terminated
- not on file
- Reason
- Potential of failing to trigger clinical scan during Bolus Tracking.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips notification dated June 26, 2026 will inform customers of the issue via an Electronic Product Radiation Correction notification. Philips will schedule an appointment with customers to update the software free of charge. 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: 2026-PD-CTAMI-108.
- Quantity
- not on file
- Distribution
- U.S. Nationwide and U.S. Territories distribution.
- Lot, serial or model codes
- Device Identifier: (01)00884838085015, (01)00884838105508.
- 510(k) numbers
- ["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