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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Qube Compact Monitor

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  Class 2 Device Recall Spacelabs Healthcare Qube Compact Monitor see related information
Date Initiated by Firm June 06, 2014
Date Posted June 23, 2014
Recall Status1 Terminated 3 on February 17, 2015
Recall Number Z-1852-2014
Recall Event ID 68491
510(K)Number K120616  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Spacelabs Healthcare Qube Compact Monitor, Model 91390.

Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
Code Information n/a
Recalling Firm/
Manufacturer		 Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
For Additional Information Contact
800-522-7025 Ext. 2
Manufacturer Reason
for Recall		 Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.
FDA Determined
Cause 2		 Component design/selection
Action Spacelabs Healthcare Snoqualmie, WA sent an Urgent Medical Device Correction letter, dated June 6, 2014, to all consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter instructed customers using docking station ready qube monitors with qube docking stations immediately advise their staff of this situation; and, to follow the steps provided, if they continue to use a docking station ready qube monitor with a docking station. Spacelabs Healthcare will contact customers at the earliest possible date to schedule a convenient time for Spacelabs to correct customer's affected qube monitors at no cost. Questions should be directed to Spacelabs Healthcare Technical Support at 1-800-522-7025.
Quantity in Commerce 3383 in the USA; 1459 outside the USA
Distribution Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
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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