ProxiDiagnost upgrade- A Multi-functional general recall
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Why was ProxiDiagnost upgrade- A Multi-functional general recalled?
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)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
- Recalling firm
- Philips North America
- Quantity
- 20 units: 16 units US; 4 units OUS
- Distribution
- Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
- Recall date
- February 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)