Reported Nov 21, 2018 · Completed
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Invivo 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: Invivo Corporation · 12151 Research Pkwy Ste 200 · Orlando, FL · 32826-3286
Is this the product you have?
- Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
- Lot codes and dates
- Model Number 453564669081
- System Serial Number (UDI)US1814000001 ((01)00884838091474(21)US1814000001), US1814000002 ((01)00884838091474(21)US1814000002), US1814000003 ((01)00884838091474(21)US1814000003), US1814000004 ((01)00884838091474(21)US1814000004), US1814000006 ((01)00884838091474(21)US1814000006), US1814000007 ((01)00884838091474(21)US1814000007), US1814000008 ((01)00884838091474(21)US1814000008), US1814000011 ((01)00884838091474(21)US1814000011), US1814000012 ((01)00884838091474(21)US1814000012), US1814000013 ((01)00884838091474(21)US1814000013), US1814000014 ((01)00884838091474(21)US1814000014), US1814000016 ((01)00884838091474(21)US1814000016), US1814000017 ((01)00884838091474(21)US1814000017), US1814000018 ((01)00884838091474(21)US1814000018), US1814000019 ((01)00884838091474(21)US1814000019), US1814000020 ((01)00884838091474(21)US1814000020), US1814000022 ((01)00884838091474(21)US1814000022), US1814000023 ((01)00884838091474(21)US1814000023), US1814000024 ((01)00884838091474(21)US1814000024), US1814000027 ((01)00884838091474(21)US1814000027), US1814000028 ((01)00884838091474(21)US1814000028), US1814000029 ((01)00884838091474(21)US1814000029), US1814000030 ((01)00884838091474(21)US1814000030), US1814000031 ((01)00884838091474(21)US1814000031), US1814000032 ((01)00884838091474(21)US1814000032), US1814000033 ((01)00884838091474(21)US1814000033), US1814000034 ((01)00884838091474(21)US1814000034), US1814000035 ((01)00884838091474(21)US1814000035), US1814000036 ((01)00884838091474(21)US1814000036), US1814000037 ((01)00884838091474(21)US1814000037), US1814000038 ((01)00884838091474(21)US1814000038), US1814000039 ((01)00884838091474(21)US1814000039), US1814000040 ((01)00884838091474(21)US1814000040), US1814000041 ((01)00884838091474(21)US1814000041), US1814000043 ((01)00884838091474(21)US1814000043), US1814000044 ((01)00884838091474(21)US1814000044), US1814000045 ((01)00884838091474(21)US1814000045), US1814000046 ((01)00884838091474(21)US1814000046), US1814000047 ((01)00884838091474(21)US1814000047), US1814000048 ((01)00884838091474(21)US1814000048), US1814000049 ((01)00884838091474(21)US1814000049), US1814000050 ((01)00884838091474(21)US1814000050), US1814000051 ((01)00884838091474(21)US1814000051), US1814000052 ((01)00884838091474(21)US1814000052), US1814000053 ((01)00884838091474(21)US1814000053), US1814000054 ((01)00884838091474(21)US1814000054), US1814000055 ((01)00884838091474(21)US1814000055), US1814000056 ((01)00884838091474(21)US1814000056), US1814000058 ((01)00884838091474(21)US1814000058), US1814000059 ((01)00884838091474(21)US1814000059), US1814000060 ((01)00884838091474(21)US1814000060), US1814000061 ((01)00884838091474(21)US1814000061), US1814000062 ((01)00884838091474(21)US1814000062), US1814000063 ((01)00884838091474(21)US1814000063), US1814000064 ((01)00884838091474(21)US1814000064), US1814000065 ((01)00884838091474(21)US1814000065), US1814000066 ((01)00884838091474(21)US1814000066), US1814000067 ((01)00884838091474(21)US1814000067), US1814000068 ((01)00884838091474(21)US1814000068), US1814000069 ((01)00884838091474(21)US1814000069), US1814000070 ((01)00884838091474(21)US1814000070), US1814000072 ((01)00884838091474(21)US1814000072), US1814000074 ((01)00884838091474(21)US1814000074), US1814000078 ((01)00884838091474(21)US1814000078), US1814000081 ((01)00884838091474(21)US1814000081), US1814000082 ((01)00884838091474(21)US1814000082), US1814000083 ((01)00884838091474(21)US1814000083), US1814000084 ((01)00884838091474(21)US1814000084), US1814000085 ((01)00884838091474(21)US1814000085), US1814000086 ((01)00884838091474(21)US1814000086), US1814000087 ((01)00884838091474(21)US1814000087), US1814000088 ((01)00884838091474(21)US1814000088), US1814000089 ((01)00884838091474(21)US1814000089), US1814000092 ((01)00884838091474(21)US1814000092), US1814000094 ((01)00884838091474(21)US1814000094), US1814000096 ((01)00884838091474(21)US1814000096)
- Amount recalled
- 76 units
Why it was recalled
The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
This product could cause temporary or reversible health problems — stop using it.
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