Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient dataUDI-DI 10841522107177
What the firm is doing
On 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
DistributionShow detailsHide
US: 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
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0809-2025
- 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.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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