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CARESCAPE Software

by GE Healthcare Finland Oy

Model Version 3 (build 3.2)510(k) K132533

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132533↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00840682147811 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00122GT Basic UDI-DI 00840682147811UDI-DIDate20 Apr 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK132533 Date4 Dec 2013ClearedStatusActive

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

7 recalls · 6 ongoing · FDA

    • Ongoing Z-0453-2026 FDA Class II initiated 26 Sep 2025

    Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

  • 3 recalls, same reason

    • Ongoing Z-2170-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-2171-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-2172-2024 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.

  • 2 recalls, same reason

    • Ongoing Z-0096-2019 FDA Class II initiated 4 Sep 2018
    • Ongoing Z-0095-2019 FDA Class II initiated 4 Sep 2018

    When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

    • Terminated Z-1606-2015 FDA Class II initiated 4 May 2015

    The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatment

Coverage

2 jurisdictions

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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Carescape EUDAMED
CARESCAPE Software GUDID
Generic Name
Physiologic monitor-installed software
Model / Ref / Catalog
Version 3 (build 3.2) EUDAMED
3.2 GUDID
Primary DI / UDI-DI
00840682147811
Basic UDI-DI
8406821BUG00122GT, B-00840682147811
510(k) Number
FDA Product Code
MHX, BZL, BZK, BZQ, DSI, GWJ, KRB, OLW, CAP, OMC, DSK, FLL, NHO, CBQ, DXN, CBR, CBS, GWQ, CCK, DQK, NHQ, QEM, MLD, DSJ, CCL, DRT, ORT, KOI, OLT, DPS, DPZ, DQA, NHP, DXG, MUD
EMDN Code
Z1203020282 Multi-parameter monitors - software accessories
GMDN Term
Physiologic monitor-installed software
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1025 510(k)GUDID
868.1730 GUDID
868.1850 GUDID
868.2375 GUDID
882.1900 GUDID
870.1915 GUDID
882.1400 GUDID
868.2600 GUDID
870.1110 GUDID
880.2910 GUDID
868.1500 GUDID
870.1130 GUDID
868.1700 GUDID
868.1620 GUDID
868.1400 GUDID
870.1425 GUDID
870.2700 GUDID
870.1100 GUDID
868.1720 GUDID
870.2300 GUDID
868.2775 GUDID
870.2340 GUDID
870.2710 GUDID
870.1435 GUDID
Special Device Type
Software
-1192
EU market of registration
Finland
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
Version 3 (build 3.2)
510(k)
—
GUDID
3.2
510(k) NumberEUDAMED
—
510(k)
K132533
GUDID
K213181
K213336
K213363
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number

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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No