GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0
Summary
The FDA issued a Class II for GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orde by GE Medical Systems Information Technologies Inc. Reason: GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (.
Details
Source
Device Recall
External ID
Z-2243-2026
Action Date
2026-06-03
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.
Quantity Affected: 14 units
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).
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-24
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 129 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems Information Technologies Inc has 24 FDA actions in our database, including 11 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems Information Technologies Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems Information Technologies Inc have FDA actions?
GE Medical Systems Information Technologies Inc has 24 FDA actions in our database, including 11 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2243-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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