FDA Medical Device Recalls (openFDA)
Philips Healthcare: Incisive CT, software version 5.0
- Recall number
- Z-2520-2023
- Recalling firm
- Philips Healthcare
- Product
- Incisive CT, software version 5.0
- Status
- Open, Classified
- Initiated
- 2023-08-02
- Posted
- 2023-09-30
- Terminated
- not on file
- Reason
- Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips will inform customers of the issue via an Electronic Product Radiation Defect notification. Philips will schedule an appointment with customers to install the software update.
- Quantity
- 140 systems
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- software version 5.0
- 510(k) numbers
- ["K180015","K211168","K212441"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3016860078
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
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