Reported Dec 31, 2014 · Terminated
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485…
Mindray DS USA, Inc. dba 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. dba Mindray North America · 800 MacArthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
- Lot codes and dates
- DPM 6 - PNC-047-000199-00
- and DPM 7 - PNC-047-000200-00
- IBP Module P/N6800-30-50485
- Amount recalled
- 455 units
Where it was sold
Why it was recalled
Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
This product could cause temporary or reversible health problems — stop using it.
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