GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Servi...
FDA Device Recall #Z-2243-2026 - Class II, April 24, 2026
Recall Summary
| Recall Number | Z-2243-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 24, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems Information Technologies Inc |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 14 units |
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)
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 Pattern
Worldwide distribution.
Lot / Code Information
UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.
Other Recalls from GE Medical Systems Information Techno...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3038-2026 | Class II | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 56... | Jul 20, 2026 |
| Z-3039-2026 | Class II | FRU (Field replaceable unit), PORTRAIT CORE SER... | Jul 20, 2026 |
| Z-3037-2026 | Class II | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5... | Jul 20, 2026 |
| Z-3036-2026 | Class II | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Jul 20, 2026 |
| Z-2878-2026 | Class II | GE Healthcare Portrait Core Services SW V 1.2.0... | Jul 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.