Z-0809-2025Class II

Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with...

Name: Z-0809-2025 Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with...
Creator: Spacelabs Healthcare, Inc.
Published: 2024-11-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-11-25 / Open, Classified / root cause: labeling and UDI

FDA source

Spacelabs Healthcare, Inc. began a recall of Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data on 2024-11-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0809-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-25
Posted: 2025-01-07
Recalling firm: GE Healthcare
Product: Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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
Quantity in commerce: 2265
Distribution: 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
Product codes and lots: Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0809-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0809-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-07

Product code MHX

K141156Class IISpacelabs Healthcare Telemetry ReceiverSpacelabs Healthcare / cleared 2014-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)