Data Foundry

Medical device recalls 2013

Spacelabs Healthcare elance Vital Signs Monitor — Class II medical device recall Z-0188-2014

Terminated recall by Spacelabs Healthcare, Llc, reported 2013-11-20, distributed in PR. Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor wi

Recall numberZ-0188-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSpacelabs Healthcare, Llc, Snoqualmie, WA, United States
Recall initiated2013-10-17
Classified2013-11-08
Reported by FDA2013-11-20
Terminated2014-02-25
DistributedPR
Countries outside the USFR, ID, KR, NI, PH, TW
Serial numbers3300-203410
Model numbers93300

Product

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

Reason for recall

Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

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-0188-2014. 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.