Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product ...

FDA Device Recall #Z-3143-2026 - Class II, July 30, 2026

Recall Summary

Recall Number Z-3143-2026
Classification Class II - Moderate risk
Date Initiated July 30, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Medical Systems Information Technologies Inc
Location Waukesha, WI
Product Type Devices
Quantity 29,570 (23,632 US; 5,938 OUS)

Product Description

Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV

Reason for Recall

Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

Distribution Pattern

Worldwide - US Nationwide distribution.

Lot / Code Information

5867474-04 UDI-DI 00195278343512 Device Serial Numbers begin with STU 5867474-13 UDI-DI 00195278516367 Device Serial Numbers begin with STU 5867474-03 UDI-DI 00195278343383 Device Serial Numbers begin with STV

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.