medical Class II Updated 2023-10-11

Philips Healthcare recalls Incisive CT, software version 5.0

Recalled Product

Incisive CT, software version 5.0


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: software version 5.0
View official government recall

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