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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/Monitoring Devices

Philips North America Llc: DIVA Widescreen Touch Displays Recalled Due to Potential Alarm Failures

Agency Publication Date: September 30, 2024
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Summary

Philips North America is recalling 555 units of the DIVA 24-inch Widescreen LCD Touch Display used with the Philips Patient Information Center (PIC iX) system. The display can malfunction by generating ghost touch inputs without any user being present, which may lead to the system automatically acknowledging and silencing critical patient alarms without medical staff seeing them. This recall affects Model RGD2461AMI with specific serial numbers distributed across several states and countries.

Risk

If the monitor incorrectly clears a patient alarm on its own, healthcare providers may not be alerted to dangerous changes in a patient's condition. This delay in medical response could lead to serious patient harm because the equipment fails to notify staff of an emergency situation.

What You Should Do

  1. Check the model number and serial number on your DIVA 24-inch Widescreen LCD Touch Display to see if it is included in this recall. Affected units are Model RGD2461AMI, Philips Part # 866126.
  2. Review the extensive list of affected serial numbers provided by Philips, which include codes starting with D0122190G, D0122220G, D0122270G, D0122360G, D0122380G, and D0122390G.
  3. If your serial number is on the list, immediately contact your healthcare provider or Philips North America for specific instructions on how to address the touch input defect.
  4. Report any malfunctions or patient safety incidents related to these displays to Philips or your facility's biomedical engineering department.
  5. Contact Philips North America at their Cambridge, Massachusetts headquarters or your local Philips service representative for further technical guidance and potential corrective actions.
  6. For additional information, you can contact the FDA medical device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action and technical guidance

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

Affected Products

Product: DIVA 24 Inch Widescreen LCD Touch Display
Model / REF:
RGD2461AMI
866126
Lot Numbers (555):
D0122190G0002
D0122190G0004
D0122190G0005
D0122190G0006
D0122190G0008
D0122190G0009
D0122190G0010
D0122190G0011
D0122190G0012
D0122190G0013
D0122190G0016
D0122190G0017
D0122190G0018
D0122190G0019
D0122190G0020
D0122190G0021
D0122190G0022
D0122190G0023
D0122190G0024
D0122190G0025
D0122190G0026
D0122190G0027
D0122190G0028
D0122190G0029
D0122190G0032
D0122190G0034
D0122190G0035
D0122190G0036
D0122190G0037
D0122190G0041
D0122190G0042
D0122190G0043
D0122190G0047
D0122190G0049
D0122190G0050
D0122190G0051
D0122190G0052
D0122190G0055
D0122190G0056
D0122190G0058
D0122190G0060
D0122190G0061
D0122190G0063
D0122190G0064
D0122190G0065
D0122190G0066
D0122190G0067
D0122190G0068
D0122190G0069
D0122190G0070

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95316
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized Philips medical equipment distributors
Manufactured In: United States
Units Affected: 555 units
Distributed To: California, Illinois, Maine, North Carolina, New Jersey, New Mexico, New York, Ohio, Virginia, Washington

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.