Z-2537-2020Class II

VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare...

Name: Z-2537-2020 VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare...
Creator: Vitalconnect Inc.
Published: 2020-05-21
License: https://open.fda.gov/license/

VitalConnect, Inc. / initiated 2020-05-21 / Terminated / root cause: software

FDA source

Vitalconnect Inc. began a recall of VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data... on 2020-05-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2537-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-21
Posted: 2020-07-10
Terminated: 2021-05-13
Recalling firm: VitalConnect, Inc.
Product: 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.
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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]
Quantity in commerce: 7
Distribution: U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
Product codes and lots: Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2537-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2537-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-08

Product code DRG

K193343Class IIVista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)Vitalconnect, Inc. / cleared 2020-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)