MR Patient Care Portal 5000 (Desktop Unit)
Medical device recall Z-0004-2023. Published in FDA’s Enforcement Report on Oct 12, 2022.
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 12, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 25 states named in where it went
- 115 US; 193 ROW 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?
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
115 US; 193 ROW, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
01.02.00 - United States, Puerto Rico, Guam 01.01.00 - ROW UDI-DI: 00884838091948 Impacted serial numbers: US04100115 US04100116 US04100117 US04100118 US04100119 US04100120 US04100121 US04100122 US04100123 US04100124 US04100125 US04100126…
Every code shown here, 1,999 characters
01.02.00 - United States, Puerto Rico, Guam 01.01.00 - ROW UDI-DI: 00884838091948 Impacted serial numbers: US04100115 US04100116 US04100117 US04100118 US04100119 US04100120 US04100121 US04100122 US04100123 US04100124 US04100125 US04100126 US04100127 US04100128 US04100129 US04100130 US04100131 US04100132 US04100134 US04100135 US04100137 US04100138 US04100139 US04100140 US04100141 US04100142 US04100143 US04100144 US04100145 US04100146 US04100147 US04100148 US04100150 US04100151 US04100152 US04100154 US04100155 US04100156 US04100157 US04100158 US04100159 US04100160 US04100161 US04100162 US04100163 US04100164 US04100165 US04100166 US04100167 US04100168 US04100169 US04100170 US04100171 US04100172 US04100173 US04100174 US04100175 US04100177 US04100178 US04100179 US04100182 US04100185 US04100187 US04100189 US04100190 US04100191 US04100192 US04100193 US04100194 US04100195 US04100196 US04100197 US04100200 US04100201 US04100202 US04100203 US04100204 US04100205 US04100207 US04100208 US04100209 US04100210 US04100211 US04100213 US04100214 US04100215 US04100216 US04100217 US04100218 US04100219 US04100220 US04100221 US04100222 US04100224 US04100225 US04100226 US04100227 US04100228 US04100229 US04100230 US04100231 US04100232 US04100233 US04100234 US04100235 US04100237 US04100238 US04100239 US04100240 US04100241 US04100242 US04100244 US04100245 US04100246 US04100247 US04100248 US04100250 US04100251 US04100252 US04100253 US04100254 US04100255 US04100256 US04100257 US04100258 US04100260 US04100261 US04100262 US04100263 US04100264 US04100266 US04100267 US04100268 US04100269 US04100270 US04100271 US04100272 US04100273 US04100274 US04100275 US04100276 US04100277 US04100278 US04100279 US04100280 US04100282 US04100284 US04100285 US04100286 US04100287 US04100288 US04100289 US04100290 US04100292 US04100293 US04100294 US04100295 US04100296 US04100297 US04100298 US04100299 US04100300 US04100302 US04100303 US04100304 US04100305 US04100306 US04100307 US04100309 US04100310 US04100311 US04100312…
FDA’s list runs to 3,494 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.
Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy Malta Netherlands Norway Poland Portugal Qatar Singapore Slovakia Spain Sweden Switzerland United Kingdom
The states and territories these words name
25 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- North Carolina
- Nebraska
- New Jersey
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Vermont
- Washington
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 6, 2022.
- FDA classified it on Oct 3, 2022.
- FDA’s Enforcement Report published it on Oct 12, 2022.
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 3,494 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
-
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.