| Date Initiated by Firm |
December 15, 2023 |
| Date Posted |
February 09, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1073-2024 |
| Recall Event ID |
93773 |
| 510(K)Number |
K212837
|
| Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
|
| Product |
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Ref:706150
|
| Code Information |
UDI: N/A
Serial Numbers US:
4
5
6
7
8
9
11
12
13
14
17
18
61
692222229
692222254
692222263
Serial Numbers OUS:
53
56
65
692222227
|
Recalling Firm/
Manufacturer |
Philips North America
222 Jacobs St
Cambridge MA 02141-2296
|
| For Additional Information Contact |
Customer Care Solution Center
800-722-9377
|
Manufacturer Reason
for Recall |
Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image.
Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)
|
FDA Determined
Cause 2 |
Software design |
| Action |
Philips issued URGENT Medical Device Correction ProxiDiagnost N90 1.1 and ProxiDiagnost Upgrade on 12/15/2024. Letter states reason for recall, health risk and action to take:
For Issues 1 and 2:
" To avoid previous patient data from being represented as current patient data, ensure all images
have been exported from the previous RAD exam before starting a new examination.
" Correct images will be square shape and wrong images can be recognized by a different patient
anatomy and rectangular shape. If you identify a wrong image, flag the incorrect
images and only export not flagged images for the current examination to PACS (See figure. Refer to Appendix A for specific details regarding the other issue descriptions and advice on actions to be taken.
" Customers can continue using affected systems in accordance with the intended use.
" Circulate this notice to all users of this device so that they are aware of the issue.
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 Notice, understanding of the issue, and required actions to be taken.
A Field Service Engineer (FSE) will contact you to schedule a time to visit your site and install the
software upgrade to resolve the issues (Reference FCO70600110). Philips plans to start implementing the solution in Q2 2024.
The software upgrade will also include software enhancements to improve clinical experience.
If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
|
| Quantity in Commerce |
20 units |
| Distribution |
Nationwide
Foreign:
Australia
Germany
India
Italy
Malaysia
Panama
Thailand
|
| 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.
|
| 510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = Philips Medical Systems DMC GmbH
|
