Z-1608-2015Class II

Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central...

Name: Z-1608-2015 Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central...
Creator: Spacelabs Healthcare Inc
Published: 2015-05-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-05-08 / Terminated / root cause: software

FDA source

Spacelabs Healthcare Inc began a recall of Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs... on 2015-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1608-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-05-13
Terminated: 2015-11-05
Recalling firm: GE Healthcare
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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).
Root cause tag: software
FDA root cause: Software design
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
Quantity in commerce: 5 units distributed in the US
Distribution: distributed in North Carolina, Texas, and Wyoming
Product codes and lots: Serial Numbers: 1390-000054, 1390-000064, 1390-000313, 1390-000047, 1390-000898.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1608-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1608-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-13

Product code MHX

K120616Class IISpacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc. / cleared 2012-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)