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U.S. Department of Health and Human Services

Class 2 Device Recall DIVA 24 Inch Widescreen LCD Touch Display

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 Class 2 Device Recall DIVA 24 Inch Widescreen LCD Touch Displaysee related information
Date Initiated by FirmFebruary 15, 2024
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3312-2024
Recall Event ID 95316
510(K)NumberK153702 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductDIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
Code Information 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 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D0122190G0375 D0122190G0376 D0122190G0377 D0122190G0378 D0122190G0379 D0122190G0380 D0122190G0381 D0122190G0383 D0122190G0386 D0122190G0391 D0122190G0392 D0122190G0393 D0122190G0394 D0122190G0395 D0122190G0396 D0122190G0397 D0122190G0398 D0122190G0399 D0122190G0400 D0122220G0404 D0122220G0406 D0122220G0409 D0122220G0413 D0122220G0419 D0122220G0422 D0122220G0447 D0122220G0455 D0122220G0476 D0122220G0480 D0122220G0489 D0122220G0490 D0122220G0497 D0122220G0498 D0122220G0500 D0122220G0503 D0122220G0504 D0122220G0505 D0122220G0506 D0122220G0507 D0122220G0509 D0122220G0510 D0122220G0512 D0122220G0515 D0122220G0516 D0122220G0519 D0122220G0521 D0122220G0531 D0122220G0533 D0122220G0536 D0122220G0539 D0122220G0543 D0122220G0544 D0122220G0556 D0122220G0557 D0122220G0561 D0122220G0562 D0122220G0574 D0122220G0575 D0122220G0577 D0122220G0592 D0122220G0599 D0122220G0600 D0122220G0642 D0122220G0681 D0122270G0704 D0122270G0705 D0122270G0706 D0122270G0714 D0122270G0715 D0122270G0718 D0122270G0719 D0122270G0720 D0122270G0721 D0122270G0722 D0122270G0723 D0122270G0724 D0122270G0732 D0122270G0734 D0122270G0740 D0122270G0748 D0122270G0758 D0122270G0759 D0122270G0762 D0122270G0763 D0122270G0765 D0122270G0768 D0122270G0775 D0122270G0776 D0122270G0778 D0122270G0786 D0122270G0818 D0122270G0821 D0122270G0823 D0122270G0826 D0122270G0828 D0122270G0830 D0122270G0833 D0122270G0834 D0122270G0835 D0122270G0840 D0122270G0841 D0122270G0842 D0122270G0843 D0122270G0846 D0122270G0851 D0122270G0858 D0122270G0862 D0122270G0863 D0122270G0870 D0122270G0873 D0122270G0876 D0122270G0883 D0122270G0893 D0122270G0902 D0122270G0905 D0122270G0907 D0122270G0908 D0122270G0909 D0122270G0911 D0122270G0913 D0122270G0914 D0122270G0916 D0122270G0917 D0122270G0918 D0122270G0920 D0122270G0921 D0122270G0922 D0122270G0923 D0122270G0926 D0122270G0927 D0122270G0928 D0122270G0932 D0122270G0933 D0122270G0934 D0122270G0935 D0122270G0936 D0122270G0937 D0122270G0939 D0122270G0940 D0122270G0941 D0122270G0942 D0122270G0943 D0122270G0945 D0122270G0947 D0122270G0948 D0122270G0950 D0122270G0963 D0122270G0968 D0122270G0969 D0122270G0978 D0122270G0986 D0122270G0987 D0122270G0989 D0122270G0990 D0122270G0991 D0122270G0992 D0122270G0993 D0122270G0995 D0122270G0996 D0122270G0997 D0122270G0998 D0122270G0999 D0122270G1000 D0122270G1001 D0122360G1010 D0122360G1012 D0122360G1025 D0122360G1026 D0122360G1033 D0122360G1039 D0122360G1043 D0122360G1044 D0122360G1067 D0122360G1068 D0122360G1071 D0122360G1077 D0122360G1079 D0122360G1083 D0122360G1103 D0122360G1104 D0122360G1107 D0122360G1113 D0122360G1114 D0122360G1118 D0122360G1143 D0122360G1148 D0122360G1152 D0122360G1161 D0122360G1163 D0122360G1178 D0122360G1207 D0122360G1216 D0122360G1220 D0122360G1233 D0122360G1270 D0122360G1272 D0122360G1273 D0122360G1274 D0122360G1287 D0122360G1290 D0122360G1303 D0122360G1306 D0122360G1307 D0122360G1311 D0122360G1321 D0122360G1324 D0122360G1326 D0122360G1327 D0122360G1328 D0122360G1341 D0122360G1345 D0122360G1371 D0122360G1379 D0122380G1423 D0122380G1425 D0122380G1452 D0122380G1518 D0122380G1533 D0122380G1536 D0122380G1548 D0122380G1562 D0122380G1573 D0122380G1587 D0122380G1621 D0122380G1678 D0122380G1685 D0122380G1711 D0122380G1720 D0122380G1764 D0122390G1772 D0122390G1773 D0122390G1774 D0122390G1776 D0122390G1781 D0122390G1783 D0122390G1784 D0122390G1788 D0122390G1789 D0122390G1797 D0122390G1801 D0122390G1808 D0122390G1811 D0122390G1815 D0122390G1816 D0122390G1820 D0122390G1821 D0122390G1822 D0122390G1828 D0122390G1833 D0122390G1835 D0122390G1837 D0122390G1842 D0122390G1843 D0122390G1847 D0122390G1863 D0122390G1865 D0122390G1866 D0122390G1870 D0122390G1871 D0122390G1897 D0122390G1903 D0122390G1906 D0122390G1907 D0122390G1910 D0122390G1911 D0122390G1926 D0122390G1929 D0122390G1934 D0122390G1951 D0122390G1959 D0122390G1960 D0122390G1978 D0122390G1979 D0122390G1986
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer Reason
for Recall		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 Determined
Cause 2		Device Design
ActionPhilips North America issued Important Product Information letter CR# 2023-CC-HPM-044, dated 2/15/24 to US consignees. Philips Market Organizations distribute the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Actions that should be taken by the customer / user in order to prevent risks for patients or users 1) Please be aware of the alarms that remain active even though there is an indicator that alarm has been silenced. 2) Look for the water effect on the screen edges, if these exist, take the device out of service and arrange for alternative monitoring device to be used. This notice should be passed on to all those who need to be aware within your organization or to any organization where affected devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will replace the malfunctioning DIVA 24 Inch Widescreen LCD Touch Display. If you need any further information or support concerning this issue, please contact your local Philips representative.
Quantity in Commerce555 units
DistributionWorldwide - 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.
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 = MHX
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