GE HealthCare ApexPro CARESCAPE Telemetry Server Recall

Source: FDA · Worldwide

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GE Medical Systems Information Technologies Inc is recalling 14 units of ApexPro CARESCAPE Telemetry Server (CTS) v5.0 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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.

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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

The recall affects GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit (REF #2108523-01) and ApexPro CARESCAPE Telemetry Server (CTS) v5.0. A total of 14 units are affected worldwide. Affected serial numbers are: SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA. The recall number is Z-2243-2026.

What You Should Do

No specific consumer action steps are provided in the recall notice.

Why This Matters

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

Source

FDA recall number Z-2243-2026, GE Medical Systems Information Technologies Inc.

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 14 units of ApexPro CARESCAPE Telemetry Server (CTS) v5.0 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.