Xhibit Telemetry Receiver (Spacelabs) – System Shutdown Risk (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Brand
Spacelabs Healthcare, Inc.
Lot Codes / Batch Numbers
Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
Products Sold
Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
Spacelabs Healthcare, Inc. is recalling Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with pat due to Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Telemetry receivers with affected software versions may experience unsolicited system 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 and necessary clinical intervention could be delayed.
Recommended Action
Per FDA guidance
On 11/25/2024, correction notices were emailed to customers who were asked to do the following: Firm will contact you at the earliest possible date to schedule a convenient time to update affected devices to software version 1.4.2 for XTR systems which addresses this defect. You can also contact GTS to have an FSE paged out for discussing upgrade schedule: 1-800-522-7025 and select 2 for Technical Support. Complete and submit the customer acknowledgement form: https://spacelabshealthcare.com/support/recall-reply-form/recall-reply-form-xtr-15-nov-2024/ For additional information or technical assistance, or to report an adverse event, contact: Technical Support: 1-800-522-7025 and select 2
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CO, FL, GA, ID, IL, IA, KS, LA, ME, MA, MN, MS, MO, NM, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, PR
Page updated: Jan 10, 2026