DPM 6/7 Patient Monitor Manufactured in China for recall
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…
Why was DPM 6/7 Patient Monitor Manufactured in China for recalled?
There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.
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?
K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001
- 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…
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Quantity
- 124 units
- Distribution
- Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
- Recall date
- December 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)