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