Reported Dec 26, 2018 · Terminated
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901,…
Philips Electronics North America Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
Xper Flex Cardio Physiomonitoring SystemSoftware versions 1.5.16.0322 and 1.6.1.0390Model Numbers 453564241901453564241911453564483321453564483331453564621791453564621801453564669081
- Lot codes and dates
- 14 US1537001306 45
US1251000031US1311000006US1407000009US1419000044US1438000118US1446000275US1547001419US1610001769US1625002302US1638002539US1450000330US1746001254US1311000077US1417000003US1511000589US1319000051US1537001287US1736000931US1604001618US1623002140153US1251000021US1203010332US1604001569US1407000057US1324000017420421428251616US1234000045
19160 of 160 codes
US1603001509US1617002012US1438000113US1334000026US1239000047US1203010392US14170000361213US1319000082US1608001676US1611001852US1324000025US1731000712US1609001745US1334000028US1248000022US1638002517US1638002591US1644002662US1644002668US1644002682US1546001353US1203010414US1424000022US1523000858US1547001364US1547001374US1547001394US1547001395US1610001753US1626002429US1201010146US1202010179US1244000031US1244000058US1505000520US1534001212US1738001102US1203010380US1644002701US1505000552US1523000883US1604001624US1609001735US1611001878US1611001892US1638002619US1644002625US1644002635US1644002684US1319000043US1738002731US1738002766US1738002769US1738002776US1738002782US1738002786US1738002798US1738002799US1319000061
3 1622 952 95US1529001058US1533001136US1304000016US1334000016US1529001019US1624002224US1408000049US1337000072US1109010083US1107010010US1109010111US1652000079US1511000631US1529001008US1611001899US13370000121287US1611001880US1202010156US1626002463US1407000023US1419000055US1443000212931951
25402US1433000041501834217US11090100652872083579342042
46 225 US1248000079 3586143860457350351214361591
65 6613076305265241026127713471279US1604001609672
77 US1623002184 42 328 US1319000049 943 US1608001680 394 638 US1450000312 81,684 of 1,684 codes
399US1438000150US1550001462US1623002148US1529001047US1201010120US1419000033US1537001282US1734000888US1731000740US1608001684US1738001023US1751001372358US1608001661US1251000044US1412000048US1324000026433US1511000628US1724000514US1319000069US1529001048US1234000056US1331000060US1709000218US1311000013US1517000657US1337000003US1343000078US1202010155US1231000066US1251000020US1337000022US1337000042US1408000001US1433000080US1438000133US1511000575US1511000609US1511000620US1525000947US1729000625US1623002146US1547001360US1443000187US1716000341US1239000015US1537001261184US1224000033US1234000069US1234000087US1343000021US1417000017US1419000018US1502000416US1511000608US1537001248US1731000705
81 626 2083 of 83 codes
US1746001240US1611001889US1511000621US1652000043US1716000307US1534001169US1352000019US1720000369US1720000457US1319000067US1446000246US1517000662US1419000006US1324000043US1547001383US1547001431US1738002773US1203010338US1248000083US1352000064US1709000260US1331000059US1603001510US1729000647US1511000576US1729000564US1611001890US1244000024US1625002289US1626002392US1511000619US1419000051US1203010403US1523000895US1244000033US1529000995US1244000011US1638002620US1337000070US1511000616US1604001591US1203010359US1623002139889US1202010183US1107010036785US1319000080US1319000065US1604001568US1234000053US1523000892US1443000185US1234000040US1625002295US1337000074US1203010402US1529001025US1603001556US1202010247
340 of 340 codes
362US1547001369US1724000520US1746001277US1523000844US1517000652US1624002218764US1446000236US1523000823US1529001038US1626002462US1529000993US1626002387US1319000089US1731000715US1319000022US1203010251US1203010279US1203010280US1203010308US1203010330US1203010334US1203010346US1203010352US1203010358US1203010360US1203010366US1203010371US1203010373US1203010375US1203010382US1203010398US1203010400US1203010407US1203010413US1239000027US1736000952US1734000898US1734000907US1734000909US1224000050US1304000043US1304000046US1311000007US1311000009US1311000017US1550001470US1231000061US1239000009US1251000063US1412000043US1738001126US1610001776US1407000013US1611001885US1611001923US1613001945US1108010053US1109010070
- Amount recalled
- 651 units
Why it was recalled
There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Electronics North America Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.