Spacelabs Multi-Parameter Module

• 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. 21 Apr 2015 Recall initiated FDA recalls Z-1577-2015
2. 1 Jul 2016 Recall initiated FDA recalls Z-2343-2016
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

5 earlier events are in the sections above.

510(k) Number

K103142 ↗

FDA product code

DSI

Device class

Class II

Regulation

21 CFR Part 870.1025

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DSI (Detector And Alarm, Arrhythmia).

• MODEL MR-45 AMBULATORY HOLTER MONITOR by Oxford Medilog, Inc.
• INTELLIVUE PATIENT MONITORS, MODELS MP40, MP50, MP60, MP70, MP80, MP90 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
• CARDIOMEGA-T by Grandcor Medical Systems
• COSMOS SYSTEM by Spacelabs Medical, Inc.
• HEARTRATE PLUS ECG CARDULE #1918 by Spacelabs, Inc.
• CARESCAPE CENTRAL STATION MAI800 5867474-03 by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• CARE 5000 SYSTEM by Care Systems, Inc.
• LEAP FROG by Philips Medical Systems (Cleveland), Inc.
• SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960) by SIEMENS MEDICAL SOLUTIONS USA, INC.
• SOLAR 8000M SYSTEM by General Electric Medical Systems Information Techn

• elance Vital Signs Monitor, Central Monitor Software

  Class II

  FDA 510(k) K150329 Active Cleared 5 Nov 2015

• Spacelabs Smart Disclosure System

  Class II

  FDA 510(k) K110779 Active Cleared 19 Apr 2011

• Spacelabs Arkon Anesthesia Workstation

  Class II

  FDA 510(k) K113051 Active Cleared 22 Mar 2012

• Speacelabs Multigas Module

  Class II

  FDA 510(k) K112173 Active Cleared 5 Oct 2011

See all devices from Spacelabs Healthcare Inc. →