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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 25, 2024
Date PostedJanuary 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0809-2025
Recall Event ID 95927
510(K)NumberK141156 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductXhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Code Information Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246
FEI Number 3010157426
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Inc.
35301 Se Center St
Snoqualmie WA 98065-9216
For Additional Information ContactZachary Orlowski
425-396-3300
Manufacturer Reason
for Recall		Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
FDA Determined
Cause 2		Labeling design
ActionOn 11/25/2024, correction notices were sent to customers asking them to do the following: 1) Service manual has been updated by adding a section for "Required periodic system maintenance of Spacelabs Telemetry Farm", pages 5-30 through 5-35. 2) Download current versions of the Service Manual and PM Instructions at https://manuals.spacelabshealthcare.com/ 3) You may also obtain a copy of the latest manual by contacting the firm's Technical Support. 4) Discard previous copies of these documents 5) Complete the online customer acknowledgement form which can be accessed by using URL: https://spacelabshealthcare.com/support/recall-reply-form/recall-reply-form-xtr-windows-web-proxy-issue/ For additional information or to report any adverse events as a result of this issue, please contact the firm's Technical Support 1-800-522-7025 and select 2 for Technical Support
Quantity in Commerce2265
DistributionUS: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR. OUS: Kuwait, Australia, Canada, Roumanie, Greece, Philippines, Spain, Italy, Hong Kong, Switzerland, Panama, Taiwan, Netherlands, Malaysia, Poland, Mexico, United Kingdom, Saudi Arabia, France, Czech Republic
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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