Recall record at a glance
| Official record | Z-2537-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Vitalconnect Inc. |
| Report date | Jul 15, 2020 |
| Recall initiation date | May 21, 2020 |
| Quantity | 7 |
| Location | San Jose, CA, United States |
Official product description
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring.
Why the product was recalled
A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.
Distribution information
U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
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
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