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F2-01

by GE Healthcare Finland Oy

Ref 5861293

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278524089 UDI-DI Date19 Apr 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00187HP Basic UDI-DI 00195278524089UDI-DIDate20 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2168-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-2169-2024 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.

    • Ongoing Z-2656-2023 FDA Class II initiated 8 Sep 2023

    There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Patient monitoring system module rack
Device Name
E-module Frames
Model / Ref / Catalog
5861293, F2-01
Primary DI / UDI-DI
00195278524089
Basic UDI-DI
8406821BUG00187HP
510(k) Number
FDA Product Code
MHX, KRB, DQA, OLT, NHO, CBQ, DSJ, DSI, DSK, CBR, DPZ, ORT, BZQ, MUD, DRT, CAP, QEM, MLD, DPS, NHQ, KOI, NHP, CBS, CCL, OLW, BZL, GWQ, GWJ, DXG, CCK, OMC, DQK, FLL, DXN, BZK
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Patient monitoring system module rack
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025, 870.1915, 870.2700, 882.1400, 868.1500, 870.1100, 870.1110, 868.1700, 870.2710, 868.2375, 870.2300, 868.2600, 870.2340, 868.2775, 868.1620, 868.1720, 868.1730, 882.1900, 870.1435, 868.1400, 870.1425, 880.2910, 870.1130, 868.1850
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5861293
GUDID
F2-01
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No