Moderate FDA (Devices)·Z-2737-2015·Announced 2015-09-16

Mindray DPM 7 Patient Monitors Recalled for Black Screen Display

Mindray is recalling 13 DPM 7 patient monitors because they may display a black screen, potentially preventing the display of patient data.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a display failure (black screen) which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling 13 units of the Mindray DPM 7 Monitor, a multi-parameter patient monitor. The recall was initiated because the devices may display a black screen. This defect could prevent the monitor from displaying, reviewing, storing, or alarming on multiple physiological parameters, including ECG, arrhythmia detection, ST segment analysis, and heart rate.

The affected units are identified by Lot #14A18, Part Number 6800F-PA00001, and specific serial numbers ranging from DU-46002583 to DU-46002606. These monitors were distributed to healthcare facilities in Connecticut, Iowa, Kentucky, Mississippi, Pennsylvania, Utah, and Washington.

Healthcare providers should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to Mindray for repair or replacement. Patients and consumers are not directly affected as these are professional medical devices.

The recalled product

Product: Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection,
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Category: Medical Device — Patient Monitor
Hazard: display-failure
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

Lot #14A18
PN: 6800F-PA00001
Serial Numbers: DU- 46002583
DU-46002587
DU-46002588
DU-46002589
DU-46002592
DU-46002594
DU-46002595
DU-46002596
DU-46002599
DU-46002600
DU-46002601
DU-46002605 and DU-46002606

Distribution

Distributed in 7 states:

Same manufacturer · Mindray DS USA, Inc. dba Mindray North America

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