Recall record at a glance
| Official record | Z-2261-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Report date | Jun 10, 2020 |
| Recall initiation date | Aug 30, 2019 |
| Quantity | 2197 units |
| Location | Snoqualmie, WA, United States |
Official product description
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Why the product was recalled
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
Distribution information
Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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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