FDA Device recall Z-0462-2019
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
- FDA Device
- Class II
- completed
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 by Invivo, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0462-2019 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-09-24 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | n/a |
Product
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Reason
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
Identifiers
| code_info | Model Number 453564669081; System Serial Number (UDI): US1814000001 ((01)00884838091474(21)US1814000001), US18140000…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)008848 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0462-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.