GE Medical Systems CARESCAPE Patient Data Module v2.6 Software Recall: No Apnea Alarm
GE Medical Systems recalls CARESCAPE Patient Data Module v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier. This software fails to produce visual or audible alarms for impedance respiration apnea events, potentially missing critical patient safety alerts.
Lower-risk recall
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Contact the company
What happened, in plain English
GE Medical Systems is recalling v2.6 software for their CARESCAPE Patient Data Module that's used with specific monitors. The software doesn't alert when an impedance respiration apnea event occurs, which could mean critical patient safety issues aren't detected. This affects patients in hospitals or clinics using these monitors with the outdated software. Read more at govinfonow.com/recall/73431-ge-medical-systems-carescape-patient-data-module-v2-6-software.
Source Summary by GovInfoNow · govinfonow.com/recall/73431-ge-medical-systems-carescape-patient-data-module-v2-6-software · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0202-2018
Cite this page
“GE Medical Systems CARESCAPE Patient Data Module v2.6 Software Recall: No Apnea Alarm.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73431-ge-medical-systems-carescape-patient-data-module-v2-6-software. Based on FDA recall #Z-0202-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0202-2018%22&limit=1).
Why it’s dangerous
The software fails to generate visual or audible alarms when an impedance respiration apnea event happens. This means the device might not warn healthcare staff if a patient stops breathing due to respiratory issues, which could lead to delayed treatment or complications.
Who’s affected
Healthcare facilities using GE Medical Systems CARESCAPE Monitors B850, B650, or B450 with v2.0.7 or earlier software and the v2.6 Patient Data Module software are most at risk. Patients in hospitals or clinics using these devices could be affected.
How to tell if you have this one
Check if your CARESCAPE Monitor is B850, B650, or B450 model with v2.0.7 or earlier software, and if you have the v2.6 Patient Data Module software installed. Serial numbers starting with SA314096842GA or similar listed in the recall are affected.
- Brand
GE Medical Systems- Category
Medical device
What to do — step by step
Check Software Version
Verify your Patient Data Module software version. If it's v2.6, it's affected.
Update Software
Update to the latest software version to fix the alarm issue.
Where it went and when
Where it was distributed
Distributed in New York and Wisconsin, and outside the U.S.
FDA distribution: “Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York, Wisconsin.
Recall timeline
FDA terminated this recall 3.7 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.
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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-0202-2018 (July 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0202-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.