Data Foundry

Medical device recalls 2020

Xhibit Central — Class II medical device recall Z-2261-2020

Terminated recall by Spacelabs Healthcare, Inc., reported 2020-06-10, distributed nationwide. The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of aud

Recall numberZ-2261-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSpacelabs Healthcare, Inc., Snoqualmie, WA, United States
Recall initiated2019-08-30
Classified2020-06-04
Reported by FDA2020-06-10
Terminated2024-04-18
DistributedNationwide (US)
Countries outside the USCA
Quantity2,197 units
UPC / GTIN / UDI-DI10841522100345
Model numbers96102

Product

Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

Reason for recall

The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

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-2261-2020. 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.