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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Xhibit Central Station (96102)

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  Class 2 Device Recall Spacelabs Healthcare Xhibit Central Station (96102) see related information
Date Initiated by Firm August 30, 2019
Create Date June 04, 2020
Recall Status1 Terminated 3 on April 18, 2024
Recall Number Z-2261-2020
Recall Event ID 85325
510(K)Number K122146  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Code Information Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345  
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Inc.
35301 Se Center St
Snoqualmie WA 98065-9216
For Additional Information Contact Technical Support
425-396-3300
Manufacturer Reason
for Recall		 The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Urgent Medical Device Correction letters were sent to U.S. customers on August 30, 2019 via priority service, and to foreign customers via email on September 6, 2019. The letter informed customers of the conditions under which alarm audio may be lost, and actions the customer /user can take to minimize risk to patients or users. Customers were requested to weigh the benefits versus the risks when deciding whether or not to continue to use Xhibit Central with software versions 1.3.1, 1.3.2, 1.3.3, and 1.3.4. Customers experiencing a loss of audio were informed that a complete reboot of the Xhibit Central will return the device to normal operation. Customers were requested to circulate this notification to all persons affected by the information it contains. Customers were also informed that the manufacturer would contact them to schedule a time for Spacelabs to update their Xhibit Central software. Customers with questions, requiring information, or technical assistance may contact the Technical Support group at Spacelabs Healthcare, Inc. at 1-800-522-7025 and select 2 for Technical Support.
Quantity in Commerce 2197 units
Distribution Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
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 HEALTHCARE
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