Invivo Xper Flex Cardio Physiomonitoring System: ESC Key Accidentally Closes Full
Invivo recalls Xper Flex Cardio Physiomonitoring System units with specific serial numbers due to a potential issue where pressing ESC key accidentally closes Full Disclosure Control Window during playback.
Lower-risk recall
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
Contact the company
What happened, in plain English
Invivo is recalling certain Xper Flex Cardio Physiomonitoring Systems that may close the Full Disclosure Control Window accidentally when pressing the ESC key during playback. This could lead to unintended data loss or system behavior changes. Read more at govinfonow.com/recall/72513-invivo-xper-flex-cardio-physiomonitoring-system-esc-key-accidentally-closes.
Source Summary by GovInfoNow · govinfonow.com/recall/72513-invivo-xper-flex-cardio-physiomonitoring-system-esc-key-accidentally-closes · Updated September 1, 2026 · FDA enforcement record: FDA #Z-2115-2018
Cite this page
“Invivo Xper Flex Cardio Physiomonitoring System: ESC Key Accidentally Closes Full.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72513-invivo-xper-flex-cardio-physiomonitoring-system-esc-key-accidentally-closes. Based on FDA recall #Z-2115-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2115-2018%22&limit=1).
Why it’s dangerous
While in Full Disclosure playback mode, pressing the ESC key instead of the X icon in the upper right corner can close the Full Disclosure Control Window. This may cause unintended data loss or system behavior changes during medical monitoring sessions.
Who’s affected
Medical professionals using the Xper Flex Cardio Physiomonitoring System for heart and vascular disease monitoring are likely affected. Those with the specific serial numbers listed in the recall are at risk.
How to tell if you have this one
Check if your Xper Flex Cardio Physiomonitoring System has one of the listed serial numbers (US1203010251, US1239000027, etc.) from the recall notice.
- Brand
Invivo- Category
Medical device
What to do — step by step
Check Serial Number
Verify your device's serial number against the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 33 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-2115-2018 (November 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2115-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 1, 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.