Trulink 90470

• FDA 510(k) K103142 decided 3 Mar 2011 Active
• FDA GUDID UDI-DI 10841522101601 listed 20 Dec 2016 Listed

• 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.

1. 1 Jul 2016 Recall initiated FDA recalls Z-2343-2016
2. 20 Dec 2016 Listed FDA GUDID 10841522101601
3. 12 Apr 2023 Recall initiated FDA recalls Z-1503-2023
4. 27 Feb 2026 Recall initiated FDA recalls Z-1793-2026
5. 26 Mar 2026 Recall initiated FDA recalls Z-2052-2026
6. 24 Apr 2026 Recall initiated FDA recalls Z-2245-2026
7. 24 Apr 2026 Recall initiated FDA recalls Z-2246-2026
8. 24 Apr 2026 Recall initiated FDA recalls Z-2247-2026
9. 24 Apr 2026 Recall initiated FDA recalls Z-2244-2026
10. 24 Apr 2026 Recall initiated FDA recalls Z-2243-2026

6 earlier events are in the sections above.

Trade name

Trulink

Generic name

Electrocardiographic lead set, reusable

Model / Ref / Catalog

90470, 012-0296-12

Primary DI / UDI-DI

10841522101601

510(k) Number

K103142 ↗

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

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