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U.S. Department of Health and Human Services

Class 2 Device Recall Incisive CT

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 Class 2 Device Recall Incisive CTsee related information
Date Initiated by FirmAugust 02, 2023
Date PostedSeptember 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2520-2023
Recall Event ID 93000
510(K)NumberK180015 K211168 K212441 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductIncisive CT, software version 5.0
Code Information software version 5.0
Recalling Firm/
Manufacturer
Philips Healthcare
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactDusty Leppert, CHP
978-228-0190
Manufacturer 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.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
ActionPhilips 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 Commerce140 systems
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
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