Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | 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). |
|---|---|
| Recall Number | Z-0513-2013 |
| Classification | Class II |
| Code Info | K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001 |
| Product Distributed Qty | 124 units |
| 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. |
Event Detail
| Event Id | 63614 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| City | Mahwah |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2010-08-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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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