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Recall Observatory FDA recall evidence

Device product

Incisive CT, software version 5.0

Z-2520-2023

August 02, 2023

Class II

Product summary

Firm
Philips Healthcare
Event
Event 93000
Status
Ongoing
Classification
Class II
Quantity
140 systems
Official record key
device-enforcement:Z-2520-2023

Official wording

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.

Code information: software version 5.0

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issues with compliance concerns to Subchapter J: Issue