Vitalconnect recalls VistaSolution physiological signal transmitter due to software defect that could cause brief hypoxia. Affected units have catalog number 620:2.1 and UDI 00850490007139.
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.
Vitalconnect is recalling its VistaSolution physiological signal transmitter because a software defect may cause brief hypoxia in patients. This device is used by healthcare professionals to monitor patients but is not a primary patient monitor.
The software defect prevents the system from triggering notifications when a patient's oxygen saturation drops. This could expose patients to brief hypoxia (low oxygen levels) during monitoring.
Healthcare professionals using the VistaSolution transmitter for patient monitoring. Patients receiving care through this device may be at risk if the software defect causes brief hypoxia.
Check for catalog number 6200, Vista Solution version 2.1, or UDI 00850490007139. The device is used by healthcare professionals in medical settings.
Identify the catalog number (6200), version (2.1), or UDI (00850490007139) to confirm if your device is affected.
The device is safe for use but may have a software defect that could cause brief hypoxia in patients. Vitalconnect is correcting the software to address this issue.
The risk is low as the defect only causes brief hypoxia and the software is being corrected to bring performance back into compliance.
Check the device details to see if it matches the catalog number 6200, version 2.1, or UDI 00850490007139. If affected, contact Vitalconnect for further instructions.
We’ve drafted a message you can send Vitalconnect to request your refund or repair — edit it as you like.
Subject: Recall Z-2537-2020 — Vitalconnect Vitalconnect Hello, I own a Vitalconnect that is covered by recall Z-2537-2020 from Vitalconnect. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
