device · product 1 of 1
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.
- Recall number
- Z-0532-2018
- Initiated
- January 17, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 12 systems
App-derived interpretation
Unknown
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
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