The Recall Desk
HighFDA (Devices)·Z-0742-2013·Announced 2013-02-06

Mindray Recalls DPM5 Monitors Due to Missing ST and Arrhythmia Features

Mindray is recalling 13 DPM5 vital signs monitors because ST and Arrhythmia features may not be available.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where critical monitoring features (ST and Arrhythmia) may be unavailable, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Mindray DS USA, Inc. d.b.a. Mindray North America is recalling 13 units of the Mindray DPM5 Monitor. This vital signs monitor is used on human patients in healthcare facilities.

The recall was initiated because the ST and Arrhythmia features on the affected monitors may not be available. The devices were distributed nationwide in the United States, including in Virginia, Tennessee, Florida, and Texas.

Healthcare facilities should identify affected units by checking the part number 9201F-PA000XX and the specific serial numbers listed in the recall notice. Users should contact Mindray for instructions on how to proceed with the recall.

The recalled product

Product
Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Affected units
13

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Mindray DS USA, Inc. d.b.a. Mindray North America

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