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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare qube Compact Patient Monitor, Model 91390

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  Class 2 Device Recall Spacelabs Healthcare qube Compact Patient Monitor, Model 91390 see related information
Date Initiated by Firm October 17, 2013
Date Posted November 18, 2013
Recall Status1 Terminated 3 on April 02, 2014
Recall Number Z-0351-2014
Recall Event ID 66727
510(K)Number K120616  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product 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.
Code Information SERIAL NUMBERS IN THE US:  1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020.   SERIAL NUMBER INTERNATIONAL:  1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976,  1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022,  1390-102023, and 1390-102024.
Recalling Firm/
Spacelabs Healthcare, Llc
35301 Se Center St
Snoqualmie WA 98065-9216
For Additional Information Contact
Manufacturer Reason
for Recall
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare qube Compact Monitor" letter, dated 01 November 2013, to the US consignees/customers on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to advise staff of the potential for the monitor to fail to turn ON. Spacelabs Healthcare will contact their customers at the earliest possible date to schedule a convenient time for Spacelabs to correct all of your facility's affected monitors at no cost. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Quantity in Commerce 54 units total (42 units in the US and 12 outside US)
Distribution 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.
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.