Recall Z-2537-2020 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Vitalconnect Inc.
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.
| Date | Jul 10, 2020 (initiated May 21, 2020) |
| Status | Terminated |
| Reason | 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 | 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 patient |
| Quantity | 7 |
| Distribution | U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) Vitalconnect, Inc., Apr 20, 2020 |