Xhibit Telemetry Receiver with Software, Model 96280 recallZ-0810-2025 · Spacelabs Healthcare, Inc. · initiated Nov 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software change control
What the company is doing
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
Recall details
- Recall number
- Z-0810-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 25, 2024
- Posted by the FDA
- Jan 7, 2025
- Recalling firm
- Spacelabs Healthcare, Inc.
- Quantity
- 434
- Product code
- MHX
- FDA submissions
- K141156
- 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 description
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Code information (models, lots, serial numbers)
Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Xhibit Telemetry ReceiverSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 recalls30 reports
- XTR 96280Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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