The Recall Desk
ModerateFDA (Devices)·Z-0513-2013·Announced 2012-12-19

Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations

Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.

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, but the source text explicitly states no illnesses or injuries are reported and the hazard is limited to unavailable software features, fitting the criteria for a moderate severity score.

Plain-English summary

Mindray DS USA, Inc. is recalling 124 units of DPM 6 and DPM 7 patient monitors. These devices are intended for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters, including ECG, heart rate, respiration rate, and blood pressure.

The recall is due to an issue where the following features may be unavailable: Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations. The affected units were distributed nationwide in the United States, including in Washington, Illinois, Florida, Minnesota, South Carolina, Nevada, Michigan, Tennessee, Pennsylvania, Louisiana, Nebraska, Texas, and Iowa.

Healthcare facilities should contact Mindray DS USA for further instructions regarding the recall. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
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-le
Affected units
124

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 (1)

  • K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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

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