Recall record at a glance
| Official record | Z-0809-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Report date | Jan 15, 2025 |
| Recall initiation date | Nov 25, 2024 |
| Quantity | 2265 |
| Location | Snoqualmie, WA, United States |
Official product description
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Why the product was 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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