Food, drugs, devices › Mindray DS USA, Inc. d.b.a. Mindray North America

Device recall: Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

FDA enforcement event 63800 · Class II · initiated 5 Sep 2012 · status Terminated · terminated 22 Oct 2013

DeviceVoluntary: Firm initiated1 product recordMahwah, NJ

Mindray DS USA, Inc. d.b.a. Mindray North America (Mahwah, NJ) initiated this device recall on 5 Sep 2012; FDA lists 1 product record under event 63800, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 22 Oct 2013. Initiation: voluntary: firm initiated. Mindray DS USA, Inc. d.b.a. Mindray North America has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

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

Reason for recall

"Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available."

Distribution

"US Nationwide Distribution including the states of: VA, TN, FL, & TX"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0742-2013	Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.	13 units	Class II	Terminated	6 Feb 2013

Context

88%of 2012 device events are Class II823 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Mindray DS USA, Inc. d.b.a. Mindray North America

Initiated	Product (first record)	Type	Class	Records
28 Nov 2012	BS-200 Chemistry Analyzer Designed for clinical laboratory use.	Device	Class II	1
28 Nov 2012	Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA0	Device	Class II	1
24 Sep 2012	Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X	Device	Class II	1
13 Aug 2012	Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ	Device	Class I	2
7 May 2012	V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use u	Device	Class II	1
12 May 2011	DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS)	Device	Class II	1
11 Aug 2010	DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Inten	Device	Class II	1

All 8 events for Mindray DS USA, Inc. d.b.a. Mindray North America

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution including the states of: VA, TN, FL, & TX"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Oct 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.