Recall record at a glance
| Official record | Z-1513-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Report date | Aug 17, 2022 |
| Recall initiation date | May 31, 2022 |
| Quantity | 529 |
| Location | Snoqualmie, WA, United States |
Official product description
Xhibit Telemetry Receiver, Model: 96280
Why the product was recalled
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.
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
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