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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1

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  Class 2 Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1 see related information
Date Initiated by Firm January 17, 2018
Date Posted January 25, 2018
Recall Status1 Terminated 3 on November 29, 2018
Recall Number Z-0532-2018
Recall Event ID 78989
510(K)Number K141156  
Product Classification System,network and communication,physiological monitors - Product Code MSX
Product Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms)

The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
Code Information Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290
Recalling Firm/
Manufacturer		 Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie WA 98065-9216
Manufacturer Reason
for Recall		 Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
FDA Determined
Cause 2		 Under Investigation by firm
Action On January , 2018, a customer letter was sent via priority service, return receipt requested, to all U.S. customers. International consignees will be notified on January 24 , 2018, by email. The letter stated: " Please weigh the benefits versus the risks when deciding whether or not to continue to use your Exhibit Telemetry Receiver(s) until updated as set forth below. We recommend that you brief your staff regarding the failure mode listed above." Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to update your Exhibit Telemetry Receiver(s) to software version 1.0.2 at no cost." For further questions, please call (800) 522-7025.
Quantity in Commerce 12 systems
Distribution US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
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 = MSX and Original Applicant = SPACELABS HEALTHCARE
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