Recall – Blood pressure monitor displays incorrect decimal point

Company: Suntech Medical, Inc.
Date of Enforcement Report: 7/1/2020
Class II

PRODUCT

Oscar 2, Model 250 System

Recall Number: Z-2429-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Suntech Medical, Inc. on 4/20/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1,037 units

DISTRIBUTION

U.S. Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.