Date Initiated by Firm | October 09, 2023 |
Date Posted | November 14, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0292-2024 |
Recall Event ID |
93291 |
510(K)Number | K171850 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Big Bore RT with software version V4.8.0.10421- Model: 728242
CT scanner and simulator designed for radiation oncology and therapy. |
Code Information |
UDI-DI: (01)00884838095168
Serial Numbers;
Serial Number
20094
20078
766037
20064
20051
20063
766015
766013
20053
20052
20039
766003
763011
20033
763006
20023
763004
20092
766075
768020
20093
766073
766074
766072
766071
766070
766069
766068
766065
766067
766066
766064
766061
766062
766063
766060
766059
766058
763030
766057
20086
20090
763033
763032
766080
763031
766081
766079
766078
20091
766076
766077
763010
763018
20040
766047
|
Recalling Firm/ Manufacturer |
Philips North America Llc 222 Jacobs St Cambridge MA 02141-2289
|
For Additional Information Contact | Philips Customer Care Solutions Center 800-722-9377 |
Manufacturer Reason for Recall | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen.
For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Philips issued URGENT Medical Device Correction letter (UMDC) 2023-PD-CTAMI-015)
dated 10/9/23. Letter states reason for recall, health risk and action to take:
Below are short-term precautions to take until the permanent solution is installed.
Enable the Force X/Y to 0/0 option on your device (Refer to the Instructions For Use, Section 3
Preparing for an Exam under Preferences, as well as Section 5 Summary of Scanning Workflows
under Scan Workflow). Enabling this option will avoid the issue.
After enabling the above referenced option, you may continue to use your system(s) in
accordance with the intended use.
Please complete and return the attached response form to Philips promptly and no later than
30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device
Correction Letter, understanding of the issue, and required actions to be taken.
Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed.
Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update (FCO 72800806) to resolve the issue.
If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377). |
Quantity in Commerce | 56 units |
Distribution | Nationwide
Foreign:
Austria
Belgium
Canada
China
Estonia
France
Germany
Hondorus
India
Italy
Mexico
Netherlands
Philippines
Poland
Singapore
Spain
Switzerland
Taiwan
|
Total Product Life Cycle | TPLC 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.
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510(K) Database | 510(K)s with Product Code = JAK
|