Spacelabs Healthcare Inc: Medical Device Recall in 2018 - (Recall #: Z-0532-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) 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.

Product Classification:

Class II

Date Initiated: January 17, 2018

Date Posted: February 14, 2018

Recall Number: Z-0532-2018

Event ID: 78989

Reason for Recall:

Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

Status: Terminated

Product Quantity: 12 systems

Code Information:

Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290

Distribution Pattern:

US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France

Voluntary or Mandated:

Voluntary: Firm initiated