Spacelabs qube Compact Monitor, Model 91390. The monitor… recallZ-1608-2015 · Spacelabs Healthcare Inc · initiated May 8, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Software design
What the company is doing
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
Recall details
- Recall number
- Z-1608-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 8, 2015
- Posted by the FDA
- May 13, 2015
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 5 units distributed in the US
- Product code
- MHX
- FDA submissions
- K120616
- Distribution
- distributed in North Carolina, Texas, and Wyoming
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.
Code information (models, lots, serial numbers)
Serial Numbers: 1390-000054, 1390-000064, 1390-000313, 1390-000047, 1390-000898.
Other devices under the same FDA submission
3 devices cleared under K120616 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Qube Qube Compact MonitorSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 recalls3 reports
- qube 91390Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)21 reports
- qube miniSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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