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U.S. Department of Health and Human Services

Class 2 Device Recall MR Patient Care Portal 5000

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 Class 2 Device Recall MR Patient Care Portal 5000see related information
Date Initiated by FirmSeptember 06, 2022
Date PostedOctober 04, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0004-2023
Recall Event ID 90857
510(K)NumberK212227 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductMR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Code Information 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 US04100313 US04100314 US04100317 US04100318 US04100319 US04100320 US04100321 US04100322 US04100323 US04100324 US04100326 US04100327 US04100328 US04100329 US04100330 US04100331 US04100332 US04100333 US04100334 US04100335 US04100337 US04100338 US04100340 US04100341 US04100342 US04100343 US04100344 US04100346 US04100347 US04100349 US04100350 US04100351 US04100352 US04100353 US04100354 US04100356 US04100357 US04100358 US04100359 US04100360 US04100361 US04100362 US04100363 US04100364 US04100365 US04100367 US04100368 US04100369 US04100370 US04100371 US04100372 US04100373 US04100374 US04100375 US04100376 US04100377 US04100378 US04100379 US04100381 US04100383 US04100384 US04100385 US04100386 US04100387 US04100388 US04100389 US04100390 US04100391 US04100392 US04100393 US04100394 US04100395 US04100396 US04100397 US04100398 US04100399 US04100400 US04100401 US04100402 US04100403 US04100404 US04100405 US04100406 US04100407 US04100409 US04100411 US04100412 US04100413 US04100414 US04100416 US04100419 US04100420 US04100421 US04100422 US04100423 US04100424 US04100425 US04100426 US04100427 US04100428 US04100429 US04100430 US04100431 US04100432 US04100433 US04100459 US04100616 US04100619 US04100620 US04100621 US04100623 US04100624 US04100626 US04100627 US04100628 US04100630 US04100631 US04100632 US04100634 US04100635 US04100637 US04100638 US04100639 US04100640 US04100642 US04100643 US04100644 US04100646 US04100647 US04100648 US04100649 US04100807 US04100811 US04100818 US04100821 US04100828
FEI Number 3016618143
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionOn September 6, 2022, Philips notified affected customers through URGENT Medical Device Recall letters. A Philips representative will contact customers to arrange a software update. once arranged, a Philips representative will conduct a software update on the device for the customer. Customers should share the recall information with all clinical staff to review and understand. The notice should be placed with the documentation of the MR Patient Care Portal 5000.
Quantity in Commerce115 US; 193 ROW
DistributionDomestic 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MWI
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