Oscar 2 System (Suntech) – Decimal Point Display (2020)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.

Recommended Action

Per FDA guidance

Suntech Medical Instruments, Inc. notified customers on about [DATE] via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that the device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. Suntech Medical is instructing physicians and nurses that they can still use the device and are to ignore the readings on the device display and to continue to focus on the Accuwin Pro data for diagnosis. Best practice is to disable the device display during unit configuration and to instruct the patient to ignore any data that may be visible on the display. If these steps are followed, Suntech states the device can continue to be used. The correction will include 2 options: 1. To download the service tool at https://www.suntechmed.com/oscar2-display-update-request; or 2. Customers should contact SunTech to confirm the configuration has been corrected at recallcoordinator@suntechmed.com and provide the contact person, company name, and serial numbers of corrected devices. Additionally, customers were requested to complete and return the response form via email to recallcoordinator@suntechmed.com, or they can be sent by mail to: Recall Coordinator, SunTech Medical, Inc., 507 Airport Blvd, suite 117, Morrisville, NC 27560-8200. Questions can be addressed to SunTech Medical at Email: recallcoordinator@suntechmed.com, Phone: +1-800-421-8626 or 919-654-6128