GE HealthCare ApexPro Software Recall

Source: FDA · Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

GE Medical Systems Information Technologies Inc is recalling 2187 units of GE HealthCare ApexPro v6.0 eDelivery Software due to potential loss of ECG and SpO2 monitoring.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 23, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

Which Products Are Affected

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms). 2187 units are affected. UDI (01)00195278512390(10)APv6.0.0.5. Worldwide distribution. Recall number Z-2247-2026. Classification: Class II. Status: Ongoing.

What You Should Do

The recalling firm initiated the recall via letter. No additional consumer action steps are specified in the recall notice.

Why This Matters

The recall involves devices used for patient physiological monitoring with arrhythmia detection or alarms, distributed worldwide.

Source

FDA recall number Z-2247-2026. Recalling firm: GE Medical Systems Information Technologies Inc, Waukesha, WI.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
GE Medical Systems Information Technologies Inc is recalling 2187 units of GE HealthCare ApexPro v6.0 eDelivery Software due to potential loss of ECG and SpO2 monitoring.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.