# K103142: Spacelabs Multi-Parameter Module

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare, Inc.
- Decided: Mar 3, 2011 after 129 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050605: Spacelabs Medical Multiparameter Module 91496, Spacelabs Medical, Inc. (2005) Summary page 1.

## Recalls of this device
- Apr 24, 2026 · Class II · Z-2243-2026: 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 N
- Apr 24, 2026 · Class II · Z-2246-2026: 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 N
- Apr 24, 2026 · Class II · Z-2247-2026: 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 N
- Apr 24, 2026 · Class II · Z-2245-2026: 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 N
- Apr 24, 2026 · Class II · Z-2244-2026: 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 N
- Mar 26, 2026 · Class II · Z-2052-2026: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
- Feb 27, 2026 · Class II · Z-1793-2026: 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 Cur
- Apr 12, 2023 · Class II · Z-1503-2023: 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 w
- Jul 1, 2016 · Class II · Z-2343-2016: 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 t
- Apr 21, 2015 · Class II · Z-1577-2015: 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: 010-1
- Apr 17, 2015 · Class II · Z-1542-2015: 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 
- May 8, 2014 · Class II · Z-1705-2014: A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
- Nov 3, 2011 · Not classified · Z-0690-2012: 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 comp
- Jul 13, 2011 · Not classified · Z-0776-2012: One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.

## Indications for use
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.

Source page: https://510kreport.com/device/K103142
Methodology: https://510kreport.com/methodology