Z-0810-2025Class II

Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data

Name: Z-0810-2025 Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data
Creator: Spacelabs Healthcare, Inc.
Published: 2024-11-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-11-25 / Open, Classified / root cause: software

FDA source

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

Recall record

Recall number: Z-0810-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-25
Posted: 2025-01-07
Recalling firm: GE Healthcare
Product: Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software change control
Action: 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
Quantity in commerce: 434
Distribution: US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.
Product codes and lots: Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2025	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)