# K141156: Spacelabs Healthcare Telemetry Receiver

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare
- Decided: Sep 9, 2014 after 127 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925510 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925510: Model 90478 & 90479 Telemetry Rec. Module&Housing, Spacelabs Medical, Inc. (1994) Summary page 5.

## Most influential descendants
- K160667: Anybattery C2 Rechargeable Battery (2017), 0 descendants of its own

## Recalls of this device
- Nov 25, 2024 · Class II · Z-0809-2025: Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss
- Nov 25, 2024 · Class II · Z-0810-2025: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss
- May 31, 2022 · Class II · Z-1513-2022: Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor
- Jan 17, 2018 · Class II · Z-0532-2018: Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
- Aug 25, 2016 · Class II · Z-2886-2016: The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a sing
- Mar 28, 2016 · Class II · Z-1502-2016: Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor w

## Indications for use
The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

Source page: https://510kreport.com/device/K141156
Methodology: https://510kreport.com/methodology