Device recall: DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA.…

Class II FDA enforcement event 63614. Recall start date: 11 Aug 2010. Status in the FDA record: Terminated. Termination date: 2 Aug 2013.

Reason for recall, in the words of FDA

There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.

Class II, in the words of FDA

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

Mindray DS USA, Inc. d.b.a. Mindray North America started this device recall on 11 Aug 2010. The firm address in the FDA record is in Mahwah, NJ. FDA put the recall in Class II. FDA event 63614 has 1 product record. The first FDA enforcement report date is 19 Dec 2012. The record gives the status Terminated, with the termination date 2 Aug 2013.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.

Recalling firm

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

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 63614: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0513-2013	DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST…	124 units	Class II	Terminated	19 Dec 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2010: 37
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of 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
5 Sep 2012	Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.	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

Mindray DS USA, Inc. d.b.a. Mindray North America: all 8 events

Official channels

FDA enforcement report Z-0513-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 63614. https://recallregister.com/fda/ii/63614/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
What quantity of product is in FDA event 63614?: The FDA record gives this quantity: 124 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2010 have the same class?: 89% of the 37 device events that started in 2010 are in Class II.