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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America: ProxiDiagnost N90 Systems Recalled for Image Mixing and Security Vulnerability

Agency Publication Date: February 9, 2024
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Summary

Philips North America is recalling 171 ProxiDiagnost N90 and ProxiDiagnost upgrade systems, which are multi-functional X-ray and fluoroscopy machines used in medical imaging. The recall was initiated because the Radio Fluoroscopy (RF) viewer may incorrectly display a previous patient's images when starting a new scan, potentially leading to a misdiagnosis based on the wrong patient's data. Additionally, a security vulnerability was identified in the Wireless Portable Detector configuration that could allow unauthorized individuals with physical access to the system to modify or export sensitive data to removable USB drives.

Risk

The display of incorrect patient images creates a risk of medical errors, as doctors may make treatment decisions based on the wrong clinical data. Furthermore, the security flaw allows for potential data tampering or unauthorized data theft if an individual has physical access to the hospital's imaging equipment.

What You Should Do

  1. Identify if your facility uses the ProxiDiagnost N90 or ProxiDiagnost upgrade system by checking the model and reference numbers (706100, 706110, or 706150).
  2. Check the serial number of your device against the affected list, which includes U.S. serial numbers such as 10001064 through 10001161, 20000026 through 20000086, and others listed in the recall notice.
  3. Verify if your unit has the Unique Device Identifiers (UDI) 00884838085619 or 00884838103221.
  4. Ensure that previous patient image exports are fully processed before starting a new patient scan to prevent the viewer from displaying mixed images.
  5. Secure physical access to the imaging systems to mitigate the risk of unauthorized data export via the USB port.
  6. Contact Philips North America or your healthcare provider's technical support team to receive further instructions on software updates or corrective actions.
  7. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction of mixed image issue and security vulnerability

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Model / REF:
Ref: 706100
Ref: 706110
Lot Numbers (106):
10001064
10001065
10001066
10001067
10001068
10001069
10001070
10001072
10001073
10001074
10001075
10001076
10001077
10001078
10001079
10001084
10001085
10001086
10001087
10001088
10001089
10001090
10001091
10001092
10001093
10001096
10001098
10001099
10001100
10001101
10001102
10001104
10001105
10001107
10001108
10001109
10001110
10001111
10001112
10001113
10001114
10001116
10001117
10001120
10001121
10001125
10001128
10001129
10001130
10001132
Product: ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Model / REF:
Ref: 706150
Lot Numbers:
4
5
6
7
8
9
11
12
13
14
17
18
61
692222229
692222254
692222263
53
56
65
692222227

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93773
Status: Active
Manufacturer: Philips North America
Sold By: Authorized Medical Distributors; Direct Medical Sales
Manufactured In: United States
Units Affected: 2 products (151 units; 138 units US; 13 units OUS; 20 units: 16 units US; 4 units OUS)
Distributed To: Nationwide
Agency Last Updated: January 8, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.