VistaSolution, physiological signal transmitter. A software… recallZ-2537-2020 · Vitalconnect Inc. · initiated May 21, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vitalconnect Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it 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.
FDA root cause category: Software Design Change
What the company is doing
On May 21, 2020, the firm sent a "Urgent: Medical Device Recall" notification to all affected customers via E-mail and mail. The letter stated, that the third party Sp02 continuous device notifications may not indicate an alert as intended. Therefore, the health care provider may not be notified to check the patient. Potential Hazards: A patient may have hypoxia and the designated health care provider may not be notified. The firm will be turning off the ability to set custom notifications containing continuous SP02 until the issue is resolved. The firm tells customers to monitor the patients for SPO2, as if the patients are not connected to the recalled device. The customers are informed to acknowledge the receipt of this notification by E-mail or via mail to the firm, email to: [email protected] and if any questions, then contact: Tony Wilder at phone: (408) 963-4600 or [email protected]
Recall details
- Recall number
- Z-2537-2020
- Status
- Terminated
- Initiated by the company
- May 21, 2020
- Posted by the FDA
- Jul 10, 2020
- Recalling firm
- Vitalconnect Inc.
- Quantity
- 7
- Product code
- DRG
- FDA submissions
- K193343
- Distribution
- U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
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.
Code information (models, lots, serial numbers)
Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VistaCenter 6200-01Vital Connect, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page