DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system
Medical device recall Z-3312-2024. Published in FDA’s Enforcement Report on Oct 9, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 9, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 10 states named
- 555 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
555 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: N/A Serial Numbers: D0122190G0002 D0122190G0004 D0122190G0005 D0122190G0006 D0122190G0008 D0122190G0009 D0122190G0010 D0122190G0011 D0122190G0012 D0122190G0013 D0122190G0016 D0122190G0017 D0122190G0018 D0122190G0019 D0122190G0020…
Every code shown here, 2,000 characters
GTIN: N/A Serial Numbers: 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 D0122190G0072 D0122190G0073 D0122190G0074 D0122190G0076 D0122190G0077 D0122190G0078 D0122190G0079 D0122190G0080 D0122190G0081 D0122190G0082 D0122190G0083 D0122190G0084 D0122190G0085 D0122190G0086 D0122190G0087 D0122190G0088 D0122190G0089 D0122190G0090 D0122190G0091 D0122190G0094 D0122190G0096 D0122190G0097 D0122190G0099 D0122190G0100 D0122190G0101 D0122190G0103 D0122190G0105 D0122190G0106 D0122190G0107 D0122190G0108 D0122190G0109 D0122190G0110 D0122190G0112 D0122190G0113 D0122190G0114 D0122190G0115 D0122190G0116 D0122190G0117 D0122190G0118 D0122190G0119 D0122190G0120 D0122190G0121 D0122190G0123 D0122190G0124 D0122190G0125 D0122190G0126 D0122190G0129 D0122190G0131 D0122190G0132 D0122190G0133 D0122190G0134 D0122190G0135 D0122190G0136 D0122190G0137 D0122190G0138 D0122190G0143 D0122190G0144 D0122190G0145 D0122190G0146 D0122190G0147 D0122190G0149 D0122190G0151 D0122190G0154 D0122190G0155 D0122190G0156 D0122190G0157 D0122190G0158 D0122190G0159 D0122190G0160 D0122190G0161 D0122190G0162 D0122190G0163 D0122190G0166 D0122190G0167 D0122190G0168 D0122190G0169 D0122190G0170 D0122190G0175 D0122190G0176 D0122190G0177 D0122190G0178 D0122190G0179 D0122190G0181 D0122190G0182 D0122190G0183 D0122190G0184 D0122190G0187 D0122190G0189 D0122190G0190 D0122190G0193 D0122190G0194…
FDA’s list runs to 7,795 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ, NM, NY, OH, VA, WA and the countries of Australia, Austria, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, United Kingdom.
The states and territories these words name
- California
- Illinois
- Maine
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Virginia
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 15, 2024.
- FDA classified it on Sep 30, 2024.
- FDA’s Enforcement Report published it on Oct 9, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,795 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.