Spacelabs Healthcare Xhibit Telemetry Receiver — Class II medical device recall Z-0532-2018
Terminated recall by Spacelabs Healthcare Inc, reported 2018-02-14, distributed in GA, MI, NJ, VA. Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station
| Recall number | Z-0532-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2018-01-17 |
| Classified | 2018-02-05 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-11-29 |
| Distributed | GA, MI, NJ, VA |
| Countries outside the US | FR |
| Quantity | 12 systems |
| Serial numbers | 6280-000260, 6280-000290, 6280-000327, 6280-000336, 6280-000340, 6280-000359, 6280-000495, 6280-000496, 6280-000500, 6280-000502, 6280-000503, 6280-000566 |
| Model numbers | 96280 |
Product
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.
Reason for recall
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0532-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.