V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series

FDA device recall Z-1102-2012 · posted 2012-02-24 · Terminated

Recall details

Recalling firm

Mindray DS USA, Inc. d.b.a. Mindray North America

Reason for recall

A system database corruption may occur that causes the V Series Monitor to reset.

Action taken

The firm, Mindray, sent an "URGENT PRODUCT CORRECTIVE ACTION" letter dated October 14, 2011 on October 17, 2011 via certified mail, return receipt requested, signature required to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact their Mindray Service Representative at 1-800-288-2121, to arrange for software upgrade of the V Series Monitor(s) in their facility. If you have any questions, contact Manager, Regulatory Affairs and Clinical Affairs at 201-995-8407 or email: d.arpino@mindray.com.

Root cause

Process control

Status

Terminated

Product code

DRT

Quantity affected

542 units US ; 153 units International

Distribution

Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, IN, MO, NE, PR, and SD; and countries of: Australia, Chile, Columbia, United Kingdom, and Venezula.

Date initiated

2011-10-14

Date posted

2012-02-24

Date terminated

2013-06-11

Location

Mahwah, NJ