Z-2520-2023Class II

Incisive CT, software version 5.0

Name: Z-2520-2023 Incisive CT, software version 5.0
Creator: Philips Healthcare
Published: 2023-08-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-08-02 / Open, Classified / root cause: software

FDA source

Philips Healthcare began a recall of Incisive CT, software version 5.0 on 2023-08-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2520-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-02
Posted: 2023-09-30
Recalling firm: Philips North America LLC
Product: Incisive CT, software version 5.0
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: software
FDA 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 in commerce: 140 systems
Distribution: US Nationwide Distribution
Product codes and lots: software version 5.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2520-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2520-2023	Class II	Ongoing	FDA Mandated	2023-10-11	2023-09-29

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)