CLASS II ONGOING Device recall · Reported 3 Jun 2026 · FDA Enforcement Report

GE HealthCare Apexpro v5.0 - ARK2250 recalled by GE Medical Systems

GE Medical Systems Information Technologies is recalling GE HealthCare Apexpro v5.0 - ARK2250. The recall was initiated on 24 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.

Quantity recalled14 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2243-2026
FDA event ID: 98938
Recalling firm: GE Medical Systems Information Technologies, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 24 Apr 2026
FDA classified: 28 May 2026
Reported: 3 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

24 Apr 2026	Recall initiated by company
28 May 2026	Classified by FDA	+34 days
3 Jun 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 98938

This product is part of a recall event; the main page for the event is GE HealthCare Trade IN Carescape Telemetry Server Ark recalled.

Reported	Class	Recall	Company	Reason	Where
3 Jun 2026	CLASS II	GE HealthCare Trade IN Carescape Telemetry Server Ark recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026	CLASS II	GE HealthCare ApexPro v6.0 eDelivery recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026	CLASS II	GE HealthCare Carescape Telemetry Server Ark- - North America recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026	CLASS II	GE HealthCare Iou Assy ARK2250 Carescape Telemetry Server recalled	GE Medical Systems Information Technologies	Device Malfunction	WI
3 Jun 2026	CLASS II	GE HealthCare Carescape Telemetry Server V5 Ato recalled	GE Medical Systems Information Technologies	Device Malfunction	WI

More recalls from GE Medical Systems Information Technologies

All 18

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2 Sep 2026Device	CLASS II	Portrait Core Services recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026Device	CLASS II	Fru (Field replaceable unit), Portrait Core Services SW Reload V1.1 recalled	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026Device	CLASS II	Portrait Compute And Core Services V1.2 recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026Device	CLASS II	Portrait Core Services recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
12 Aug 2026Device	CLASS II	GE Healthcare Portrait Core Services SW recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	Nationwide

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide