Z-3143-2026Class II

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

Name: Z-3143-2026 Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3...
Creator: GE Medical Systems Information Technologies Inc
Published: 2026-07-30
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies Inc / initiated 2026-07-30 / Open, Classified

FDA source

Recall record

Recall number: Z-3143-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-30
Posted: 2026-09-11
Recalling firm: GE Medical Systems Information Technologies Inc
Product: 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
Product code: DQK Computer, Diagnostic, Programmable
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 29,570 (23,632 US; 5,938 OUS)
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3143-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3143-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11

Product code DQK

K162012Class IICARESCAPE Central Station V2GE Healthcare / cleared 2016-09-15

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 2026-09-18. View this recall on fda.gov (opens on fda.gov)