Edwards Hemosphere System: Software defects may cause pre-procedural issues
Edwards Lifesciences recalls Hemosphere System components due to software defects that may cause pre-procedural issues. Affected units include HEM1 Advanced Monitor, HEMSGM10 Swan-Ganz Module, and HEMOXSC100 Oximetry Smart Cable with specific serial numbers.
Recall notice
Pre-procedural issues related to software defects
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling three medical devices: the HEM1 Advanced Monitor, HEMSGM10 Swan-Ganz Module, and HEMOXSC100 Oximetry Smart Cable. These products have software defects that could cause pre-procedural issues during medical monitoring procedures. Read more at govinfonow.com/recall/72920-edwards-hemosphere-system-software-defects-may-cause-pre-procedural-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/72920-edwards-hemosphere-system-software-defects-may-cause-pre-procedural-issues · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0496-2018
Cite this page
“Edwards Hemosphere System: Software defects may cause pre-procedural issues.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72920-edwards-hemosphere-system-software-defects-may-cause-pre-procedural-issues. Based on FDA recall #Z-0496-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0496-2018%22&limit=1).
Why it’s dangerous
The software defects in these medical monitoring devices could cause pre-procedural issues, potentially affecting the accuracy of critical patient monitoring data. This may lead to incorrect treatment decisions or complications during medical procedures.
Who’s affected
Healthcare professionals using these devices in critical care settings are most at risk. Patients receiving monitoring through these systems may be affected if the software defects cause issues during procedures.
How to tell if you have this one
Check for the specific serial numbers listed in the recall notice: HEM1 with serial numbers starting with 13800, HEMSGM10 with serial numbers starting with 13600, and HEMOXSC100 with serial numbers starting with 13700.
- Brand
Edwards Lifesciences- Category
Medical device
What to do — step by step
Check Product Serial Numbers
Verify if your device has the specific serial numbers listed in the recall notice for HEM1, HEMSGM10, or HEMOXSC100.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Georgia, Illinois, Missouri, New Mexico, Oklahoma, Oregon, South Carolina, Texas.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0496-2018 (October 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0496-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.