The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0462-2019·Announced 2018-11-21

Invivo Xper Flex Cardio Physiomonitoring System Software Recall

Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System due to a software defect that causes Invasive Blood Pressure values to freeze on the display.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a risk of temporary or medically reversible harm. The software defect causes Invasive Blood Pressure values to freeze, which is a significant functional failure in a monitoring device, but the source text does not report any specific injuries or hospitalizations.

Plain-English summary

Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System, specifically software version 1.6.0.0388. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected units were distributed to the Netherlands.

The recall is being issued because the Invasive Blood Pressure (IBP) numeric values freeze on the display when specific functions are performed. These functions include changing an IBP Site Label, activating or deactivating the mean pressure waveform display option, activating or deactivating the waveform hide option, activating or deactivating the pressure waveform filter option, or performing a Pullback. These actions can be performed using the Site Label icon, the Invasive Pressure Options Dialog, the Pullback icon, or the keyboard.

Healthcare facilities that have received these units should contact Invivo Corporation for instructions on how to resolve the issue. The recall number is Z-0462-2019.

The recalled product

Product
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Manufacturer
Invivo Corporation
Category
Medical Device — Cardiovascular Monitoring
Hazard
Affected units
76

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distribution scope not specified by the agency.

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