Recall Z-3143-2026— GE Medical Systems Information Technologies Inc

Name: FDA recall Z-3143-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-30

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2026-07-30. It names one FDA 510(k) clearance: K162012. 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. Reason: 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..

Recalling firm: GE Medical Systems Information Technologies Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-07-30
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K162012 — CARESCAPE Central Station V2GE Healthcare·cleared 2016-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.