Spacelabs Medical Patient Monitor is a Physiological — Class II medical device recall Z-2707-2014
Terminated recall by Spacelabs Healthcare Inc, reported 2014-10-01, distributed nationwide. The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms
| Recall number | Z-2707-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2014-08-26 |
| Classified | 2014-09-25 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CH, CN, CZ, DE, ES, FI, FR, GB, GR, IL, IN, IT, LK, NL, NZ, PA, PL, PY, SG, TN, UY |
| Model numbers | 91367, 91369, 91370, 91387, 91393 |
Product
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
Reason for recall
The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
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-2707-2014. 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.