Date Initiated by Firm | August 02, 2023 |
Date Posted | September 30, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2520-2023 |
Recall Event ID |
93000 |
510(K)Number | K180015 K211168 K212441 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Incisive 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 Contact | Dusty 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 |
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 |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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