Recall Z-2429-2020— Suntech Medical, Inc.

Name: FDA recall Z-2429-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-20

Class II · Terminated

Class II FDA medical device recall by Suntech Medical, Inc., initiated 2020-04-20, terminated 2023-06-13. It names one FDA 510(k) clearance: K151520. Product: Oscar 2, Model 250 System. 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: Suntech Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Terminated: 2023-06-13
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K151520 — Oscar 2Suntech Medical, Inc.·cleared 2016-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Oscar 2, Model 250 System

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.