Spacelabs Healthcare qube Compact Patient Monitor — Class II medical device recall Z-0351-2014
Terminated recall by Spacelabs Healthcare, Llc, reported 2013-11-27, distributed nationwide. Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programm
| Recall number | Z-0351-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Llc, Snoqualmie, WA, United States |
| Recall initiated | 2013-10-17 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, CA, FR, GB, NL, PL |
| Reason classes | device malfunction |
| Serial numbers | 1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003 and 17 more |
| Model numbers | 91390 |
Product
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.
Reason for recall
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
Machine access
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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.