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

FDA device recall Z-2537-2020 · posted 2020-07-10 · Terminated

Recall details

Recalling firm

Vitalconnect Inc.

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.

Action taken

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

Root cause

Software Design Change

Status

Terminated

Product code

DRG

Quantity affected

7

Distribution

U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None

Date initiated

2020-05-21

Date posted

2020-07-10

Date terminated

2021-05-13

Location

San Jose, CA

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