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Trulink 90492

by Spacelabs Healthcare (Washington), Inc 11 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

8 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841522102011 UDI-DI Date20 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

14 recalls · 8 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-2245-2026 FDA Class II initiated 24 Apr 2026 on shared 510(k) K103142
    • Ongoing Z-2246-2026 FDA Class II initiated 24 Apr 2026 on shared 510(k) K103142
    • Ongoing Z-2247-2026 FDA Class II initiated 24 Apr 2026 on shared 510(k) K103142
    • Ongoing Z-2244-2026 FDA Class II initiated 24 Apr 2026 on shared 510(k) K103142
    • Ongoing Z-2243-2026 FDA Class II initiated 24 Apr 2026 on shared 510(k) K103142

    GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

    • Ongoing Z-2052-2026 FDA Class II initiated 26 Mar 2026

    Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

    • Ongoing Z-1793-2026 FDA Class II initiated 27 Feb 2026

    Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.

    • Ongoing Z-1503-2023 FDA Class II initiated 12 Apr 2023

    Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.

    • Terminated Z-2343-2016 FDA Class II initiated 1 Jul 2016

    The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.

    • Terminated Z-1577-2015 FDA Class II initiated 21 Apr 2015

    Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.

    • Terminated Z-1542-2015 FDA Class II initiated 17 Apr 2015

    Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.

    • Terminated Z-1705-2014 FDA Class II initiated 8 May 2014

    A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.

    • Terminated Z-0690-2012 FDA Unclassified (pre-2012) initiated 3 Nov 2011

    NIBP pump inside the Ultraview SL Command Module, Model 91496, became loose. The pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail.

    • Terminated Z-0776-2012 FDA Unclassified (pre-2012) initiated 13 Jul 2011

    One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Trulink
Generic Name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
90492, 012-0498-12
Primary DI / UDI-DI
10841522102011
510(k) Number
FDA Product Code
DSI
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
870.1025
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K103142)

Show all (12)

Other devices from Spacelabs Healthcare (Washington), Inc

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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