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Open, Classified

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

FDA Recall Z-3143-2026 · Posted 2026-09-11

Recalling FirmGE Medical Systems Information Technologies Inc
Recall StatusOpen, Classified
Product CodeDQK
Date Initiated2026-07-30
Product Quantity29,570 (23,632 US; 5,938 OUS)

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.

Firm Action

On July 30, 2026, the firm sent Urgent Medical Device Correction letters to customers with affected units. This letter informs the customer of the issue and provides actions to be taken by the customer/user for continued use of the device. GE HealthCare will provide a User Manual Addendum that provides guidance regarding the prolonged startup condition.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162012CARESCAPE Central Station V2GE Healthcare · 2016-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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