Spacelabs qube Compact Monitor — Class II medical device recall Z-1608-2015
Terminated recall by Spacelabs Healthcare Inc, reported 2015-05-20, distributed in NC, TX, WY. The input power can fail even though the power source at the wall has not been interrupted. In addition, there
| Recall number | Z-1608-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2015-05-08 |
| Classified | 2015-05-13 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-11-05 |
| Distributed | NC, TX, WY |
| Quantity | 5 units |
| Serial numbers | 1390-000047, 1390-000054, 1390-000064, 1390-000313, 1390-000898 |
| Model numbers | 91390 |
Product
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays 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.
Reason for recall
The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).
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-1608-2015. 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.