Reported Jan 9, 2013 · Terminated
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS)…
Mindray DS USA, Inc. d.b.a. Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. d.b.a. Mindray North America · 800 MacArthur Blvd. · Mahwah, NJ · 07430
Is this the product you have?
- DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
- Lot codes and dates
- 510 K K080192 P/N 300BF-PA200002
- Amount recalled
- two units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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