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CARESCAPE B650 E-musb

by GE Healthcare Finland Oy

510(k) K213181

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213181↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK213181 Date13 Apr 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213181 decided 13 Apr 2022 Active
  • EUDAMED Active· +1 more in the status table

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2172-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-2171-2024 FDA Class II initiated 5 Apr 2024

    GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

Timeline

3 dated events

  1. Cleared FDA 510(k) K213181
  2. Recall initiated FDA recalls Z-2172-2024
  3. Recall initiated FDA recalls Z-2171-2024

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MHX
Device class
Class II
Regulation
21 CFR Part 870.1025
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Carescape B650 E-musb is a physiological patient monitor designed for continuous, non-invasive monitoring of vital signs, including arrhythmia detection and alarm capabilities. Classified as a Class II device under FDA regulations, it is intended for use in clinical settings to track parameters such as ECG, blood pressure, pulse oximetry, and respiratory rate, supporting real-time patient assessment and intervention.

This device is supplied as a reusable medical instrument, intended for use in hospital or critical care environments. It is not sterile at the time of shipment and must be cleaned and maintained according to manufacturer guidelines. The monitor is MRI-safe under specified conditions and is authorised for use in the United States via FDA 510(k) clearance (K213181) and compliant with EU Medical Device Regulations (MDR). It operates using external power and an optional E-musb interface for connectivity.

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