FDA Device recall Z-0004-2023
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162
- FDA Device
- Class II
- ongoing
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class II recall of MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162 by Philips North America, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0004-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-06 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | 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 |
Product
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Reason
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.
Identifiers
| code_info | 01.02.00 - United States, Puerto Rico, Guam 01.01.00 - ROW UDI-DI: 00884838091948 Impacted serial numbers: US04100115 U…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 US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0004-2023%22
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