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