Z-2243-2026Class II

GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF...

Name: Z-2243-2026 GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF...
Creator: GE Medical Systems Information Technologies Inc
Published: 2026-04-24
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2026-04-24 / Open, Classified / root cause: software

FDA source

GE Medical Systems Information Technologies Inc began a recall of GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server... on 2026-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2243-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-24
Posted: 2026-05-28
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: 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)
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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).
Root cause tag: software
FDA root cause: Software design
Action: GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 4/24/2026 by letter using a traceable means. The notice explained the the safety issue pertaining to the persistent NO COMM or OFF NETWORK condition, and provided instructions for the safe use of the device should either issue arise. "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your ApexPro CTS with Central Station for telemetry only or combination monitoring unless you observe a persistent (more than a few seconds) NO COMM or OFF NETWORK notification. If you do observe a persistent NO COMM or OFF NETWORK notification, follow the instructions below. 1. Use alternative bedside patient monitoring to ensure continuous clinical surveillance until the NO COMM or OFF NETWORK condition is resolved by GE HealthCare. NOTE: If you are using combination monitoring, it is recommended to switch ECG monitoring to the bedside monitor. 2. Immediately notify your Facility s Biomedical Engineering, IT or Service Department and contact GE HealthCare Service. 3. Verify monitoring is restored at the Central Station(s) and/or bedside monitor(s). Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please post this notification by your Central Station(s). Please retain this document for your records." "GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 14 units
Distribution: Worldwide distribution.
Product codes and lots: UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2242-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2243-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2244-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2245-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2246-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2247-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28

Product code MHX

K103142Class IISpacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc. / cleared 2011-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)