Skip to main content

Ongoing FDAEvent 99637 (1 month ago)

Carescape Central Station

Carescape Central Station may not resume patient monitoring for at least 3 minutes after restart, delaying recognition of events.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

GE Medical Systems Information Technologies Inc of Waukesha, Wisconsin is recalling the Carescape Central Station CSCS V3 MAS800 Desktop and CSCS V3 MAI800 Integrated. The device may not resume patient monitoring for at least 3 minutes following system restart, which can lead to potential delay in recognition of clinically significant events. The recall began July 30, 2026, and was added to the FDA's Enforcement Report on September 11, 2026.

The recalled devices were distributed nationwide in the US and worldwide. The recall affects 29,570 units, with 23,632 in the US and 5,938 outside the US.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI is listed.

  1. 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

    UDI-DI
    • 00195278343512
    • 00195278516367
    • 00195278343383

Details

Company began the recall
Sold in

Worldwide - US Nationwide distribution.

Event ID
99637
Recall No.
Z-3143-2026
Company
GE Medical Systems Information Technologies IncWaukesha, Wisconsin
Quantity recalled
29,570 (23,632 US; 5,938 OUS)
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from GE Medical Systems Information Technologies Inc

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration