Invivo recalls Xper Flex Cardio Physiomonitoring System software version 1.6.0.0388 due to potential freezing of invasive blood pressure readings during certain actions. Affected units have specific serial numbers listed in the recall notice.
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
Invivo is recalling a specific software version of their Xper Flex Cardio Physiomonitoring System because blood pressure readings may freeze when certain functions are used. This could lead to inaccurate monitoring of a patient's vital signs during medical procedures. Read more at govinfonow.com/recall/69824-invivo-xper-flex-cardio-physiomonitoring-software-v1-6-0-0388.
“Invivo Xper Flex Cardio Physiomonitoring Software v1.6.0.0388: Invasive Blood Pressure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69824-invivo-xper-flex-cardio-physiomonitoring-software-v1-6-0-0388. Based on FDA recall #Z-0462-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0462-2019%22&limit=1).
The FDA announced on Sept. 24, 2018, that Invivo Corporation is recalling its Xper Flex Cardio Physiomonitoring System because invasive blood pressure values may freeze on the display. The agency said owners should contact the company for a software update.
How to tell if you have it
Brand: Invivo
Product: Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
According to the FDA, the Invasive Blood Pressure numeric values will freeze on the display when specific functions are performed, such as changing an IBP Site Label or activating waveform options. The agency said this malfunction could prevent healthcare providers from seeing accurate blood pressure readings.
Context
GovInfoNow's records show Invivo Corporation has had 8 other recalls since Aug. 11, 2017. On Feb. 6, 2020, the company recalled monitors due to insufficient shielding risks. Other recent recalls of similar products include Abiomed Impella RP Flex SmartAssist (Jan. 27, 2026), Boston Scientific CRT-P Pacemakers (March 19, 2026), and Midmark IQvitals Zone Blood Pressure Device (Aug. 21, 2026).
How to tell if you have this one
Check for the software version 1.6.0.0388 on the Xper Flex system. Affected units have specific serial numbers listed in the recall notice, including US1814000001 through US1814000096.
Brand
Invivo
Product
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Xper Flex Cardio Physiomonitoring System. If it is 1.6.0.0388, it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0462-2019 (September 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0462-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.