| | Class 2 Recall
Mindray DS USA Inc. |  |
| Date Posted |
December 11, 2012 |
| Recall Number |
Z-0513-2013 |
| 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, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM). |
| Code Information |
K092449
DPM 6- p/n 6802F-PA00001
DPM 7 - p/n 6800F-PA00001
|
Recalling Firm/
Manufacturer |
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Ms. Diane Arpino
800-2882121
|
Reason for
Recall |
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.
|
| Action |
Mindray sent a "PRODUCT CORRECTIVE ACTION" letter dated August 11, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their Mindray Service Representative at 1-800-288-2121 for assistance with this issue. |
| Quantity in Commerce |
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. |
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