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Recall Observatory FDA recall evidence

Device 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.

Z-1608-2015

May 08, 2015

Class II

Product summary

Firm
Spacelabs Healthcare Inc
Event
Event 71233
Status
Terminated
Classification
Class II
Quantity
5 units distributed in the US
Official record key
device-enforcement:Z-1608-2015

Official wording

Reason: 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).

Code information: Serial Numbers: 1390-000054, 1390-000064, 1390-000313, 1390-000047, 1390-000898.

Distribution pattern: distributed in North Carolina, Texas, and Wyoming

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).