Spacelabs Healthcare Inc: Medical Device Recall in 2015 - (Recall #: Z-1608-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 8, 2015

Date Posted: May 20, 2015

Recall Number: Z-1608-2015

Event ID: 71233

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).

Status: Terminated

Product Quantity: 5 units distributed in the US

Code Information:

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

Distribution Pattern:

distributed in North Carolina, Texas, and Wyoming

Voluntary or Mandated:

Voluntary: Firm initiated