CLASS II Device recall · Reported 6 Feb 2013 · FDA Enforcement Report

Mindray DPM5 Monitor, a vital signs monitor used on human recalled

Mindray DS USA, Inc. d.b.a. Mindray North America is recalling Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare, distributed nationwide in the US. The recall was initiated on 5 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesp/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

Quantity recalled13 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0742-2013
FDA event ID: 63800
Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Sep 2012
FDA classified: 27 Jan 2013
Reported: 6 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

5 Sep 2012	Recall initiated by company
27 Jan 2013	Classified by FDA	+144 days
6 Feb 2013	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Florida Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mindray DS USA, Inc. d.b.a. Mindray North America

All 9

Reported	Class	Recall	Company	Reason	Where
3 Apr 2013Device	CLASS II	BS-200 Chemistry Analyzer Designed for clinical laboratory use recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Labeling Errors	NC, TX
20 Feb 2013Device	CLASS II	Mindray DS USA, Inc., DPM Central Monitoring System recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Device Malfunction	Nationwide
9 Jan 2013Device	CLASS II	DPM Central Station Mindray DS USA recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Device Malfunction	Nationwide
26 Dec 2012Device	CLASS II	Mindray V12 Size: N.W.: G.W.: Qty:1 recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Temperature Abuse	Nationwide
19 Dec 2012Device	CLASS II	DPM 6/7 Patient Monitor recalled by Mindray DS USA, Inc. d.b.a.	Mindray DS USA, Inc. d.b.a. Mindray North America	Temperature Abuse	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide