DPM Central Station Mindray DS USA recall: Software Issue
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information…
Why was DPM Central Station Mindray DS USA recalled?
There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
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?
510 K K080192 P/N 300BF-PA200002
- Product
- DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information…
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Quantity
- two units
- Distribution
- Nationwide Distribution including OH and GA
- Recall date
- January 9, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)