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.

Recall Insight

This FDA Devices action (record #Z-0351-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on October 17, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare, Llc is listed as the recalling firm, operating out of Snoqualmie, WA. Federal records indicate 54 units total (42 units in the US and 12 outside US) units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.