Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DS USA, Inc. d.b.a. Mindray North America appears in FDA public data with 9 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0798-2013, Class II) was initiated on November 28, 2012.
Summary
- Total Recalls
- 9 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Known Names
mindray ds usa, inc. d.b.a. mindray north america, mindray ds usa, inc. dba mindray north america
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0798-2013 | Class II | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA | November 28, 2012 |
| Z-0977-2013 | Class II | BS-200 Chemistry Analyzer Designed for clinical laboratory use. | November 28, 2012 |
| Z-0528-2013 | Class II | Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Min | September 24, 2012 |
| Z-0742-2013 | Class II | Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. | September 5, 2012 |
| Z-0290-2013 | Class I | Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur | August 13, 2012 |
| Z-0291-2013 | Class I | Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur | August 13, 2012 |
| Z-2279-2012 | Class II | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended | May 7, 2012 |
| Z-0630-2013 | Class II | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central M | May 12, 2011 |
| Z-0513-2013 | Class II | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Ma | August 11, 2010 |