Xhibit Telemetry Receiver with Software recall: Software Issue
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Why was Xhibit Telemetry Receiver with Software 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
- Product
- Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Recalling firm
- Spacelabs Healthcare, Inc.
- Quantity
- 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.
- Recall date
- January 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)