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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs qube Compact Monitor, Model 91390

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  Class 2 Device Recall Spacelabs qube Compact Monitor, Model 91390 see related information
Date Initiated by Firm May 08, 2015
Date Posted May 13, 2015
Recall Status1 Terminated 3 on November 05, 2015
Recall Number Z-1608-2015
Recall Event ID 71233
510(K)Number K120616  
Product Classification Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
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.
Code Information Serial Numbers:  1390-000054,  1390-000064,  1390-000313,  1390-000047,  1390-000898.  
Recalling Firm/
Manufacturer		 Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
For Additional Information Contact Technical Support
425-657-7200 Ext. 5970
Manufacturer 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).
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SPACELABS MEDICAL, INC.
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