FDA Medical devices recall ·
Xhibit Telemetry Receiver, Model 96280, with Service Manual recall
- Recall number
- Z-0809-2025
- Date
- (initiated November 25, 2024)
- Company / brand
- Spacelabs Healthcare, Inc.
35301 Se Center St, Snoqualmie, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2265
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246
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
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Virginia Washington Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0809-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.