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Philips Healthcare Recall 93000

Description: Incisive CT, software version 5.0

Philips Healthcare Recall 93000 Information

Mandated?FDA Mandated
Recall NumberZ-2520-2023
Event ID93000
Event DescriptionIncisive CT, software version 5.0
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity140 systems
Recall ReasonPhilips 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.
Device Classification20231011
Device Code Infosoftware version 5.0
Center Classification Date20230929
Recall Initiation Date20230802
Recalling FirmPhilips Healthcare
Initial Notification Letter
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