Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Summary
The FDA issued a Class II for Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monit by Spacelabs Healthcare, Inc.. Reason: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately.
Details
Source
Device Recall
External ID
Z-0810-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Lot/Code Info: Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
Quantity Affected: 434
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-25
Company
Snoqualmie, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spacelabs Healthcare, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spacelabs Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spacelabs Healthcare, Inc. have FDA actions?
Spacelabs Healthcare, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0810-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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