GE HealthCare CARESCAPE Telemetry Server Recall

Source: FDA · Worldwide

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GE Medical Systems Information Technologies Inc is recalling 2,366 units of the GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L 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 TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA. A total of 2,366 units are affected. The product is used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v6.0. Distribution was worldwide. The FDA recall number is Z-2246-2026. Specific serial numbers are listed in the recall notice.

What You Should Do

The recalling firm initiated the recall via letter. Consumers with affected devices should follow instructions provided in the notification from GE Medical Systems Information Technologies Inc.

Why This Matters

This Class II recall addresses a situation that may result in loss of physiological monitoring, which could lead to temporary or reversible adverse health consequences.

Source

FDA Recall Z-2246-2026 - 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 2,366 units of the GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L 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.