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

• Date Initiated by Firm: October 17, 2013
• Date Posted: November 18, 2013
• Recall Status: Terminated 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/ Manufacturer: Spacelabs Healthcare, Llc; 35301 Se Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: 800-522-7025
• 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: 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