FDAClass IIMay 21, 2014

DPM 6 Monitor in use with a Multi Parameter Module recall

DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of…

Why was DPM 6 Monitor in use with a Multi Parameter Module recalled?

The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876

Product
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of…
Recalling firm
Mindray DS USA, Inc. dba Mindray North America
Quantity
4 units
Distribution
US Nationwide Distribution in the state of OH
Recall date
May 21, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls