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.
FDA Recall Z-1608-2015 · Posted 2015-05-13
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Recalling FirmSpacelabs Healthcare Inc
Recall StatusTerminated
Product CodeMHX
Date Initiated2015-05-08
Date Terminated2015-11-05
Product Quantity5 units distributed in the US
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).
Firm Action
The firm sent the Urgent Medical Device Correction- Spacelabs Healthcare Inc.-qube Compact Monitor, Model 91390, Power Input PCBA Failure letter, dated 8 May 2015, via priority service mail to US consignees.
This letter described the affected system, problem, actions to be taken by users and corrective actions conducted by Spacelabs.
For additional information or technical assistance, please contact:
Technical Support
Spacelabs Healthcare, Inc.
35301 SE Center St.
Snoqualmie, WA 98065
1-800-522-7025 and select 2 for Technical Support
Root Cause
Software design
Distribution Pattern
distributed in North Carolina, Texas, and Wyoming
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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