DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Centra...
FDA Device Recall #Z-0630-2013 — Class II — May 12, 2011
Recall Summary
| Recall Number | Z-0630-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 12, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | two units |
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including OH and GA
Lot / Code Information
510 K K080192 P/N 300BF-PA200002
Other Recalls from Mindray DS USA, Inc. d.b.a. Mindray N...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0977-2013 | Class II | BS-200 Chemistry Analyzer Designed for clini... | Nov 28, 2012 |
| Z-0798-2013 | Class II | Mindray DS USA, Inc., DPM Central Monitoring Sy... | Nov 28, 2012 |
| Z-0528-2013 | Class II | Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.... | Sep 24, 2012 |
| Z-0742-2013 | Class II | Mindray DPM5 Monitor, a vital signs monitor us... | Sep 5, 2012 |
| Z-0291-2013 | Class I | Mindray A5 Anesthesia Delivery System Manufac... | Aug 13, 2012 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.