Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software

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.

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

• FDA enforcement recordOfficial FDA database entry for Z-0810-2025
• FDA 510(k) clearance · K141156The device's official FDA premarket clearance record
• FDA device classification · MHXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1025The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spacelabs Healthcare, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.