Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under
FDA device recall Z-1785-2010 · posted 2010-06-10 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Reason for recall
- An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.
- Action taken
- Mindray issued Corrective action letters directly to all customers beginning April 28, 2010 by certified mail, return receipt requested. consignees were informed of the affected product. For further information, contact Mindray DS USA, Inc. at 1-201-995-8391.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 24 US, 17 International
- Distribution
- Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.
- Date initiated
- 2010-04-28
- Date posted
- 2010-06-10
- Date terminated
- 2011-06-22
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PASSPORT V MONITOR, MODEL 0998-00-6100 (K091834) | Datascope Corp., Patient Monitoring Division | 2009-07-15 |