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U.S. Department of Health and Human Services

Class 2 Device Recall VistaSolution Version 2.1

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  Class 2 Device Recall VistaSolution Version 2.1 see related information
Date Initiated by Firm May 21, 2020
Date Posted July 10, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-2537-2020
Recall Event ID 85802
510(K)Number k193343  
Product Classification Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
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.
Code Information Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139
Recalling Firm/
Manufacturer		 Vitalconnect Inc.
224 Airport Pkwy Ste 300
San Jose CA 95110-1022
For Additional Information Contact Tony Wilder
408-963-4600
Manufacturer 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.
FDA Determined
Cause 2		 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: cmerrell@vitalconnect.com and if any questions, then contact: Tony Wilder at phone: (408) 963-4600 or support@vitalconnect.com
Quantity in Commerce 7
Distribution U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRG and Original Applicant = VitalConnect, Inc.
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