Recall Z-0528-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and A
| Date | Dec 17, 2012 (initiated Sep 24, 2012) |
| Status | Terminated |
| Reason | Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. |
| Root cause | Nonconforming Material/Component |
| Action | Mindray issued an "Urgent: V Series Monitoring System Corrective Action" letter dated 9/24/2012 via certified mail with return receipt verification to all hospitals. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 to arrange for relplacement of the affected product. For questions regarding this recall call 201-995-8407. |
| Quantity | 206 units (180 units domestic, 26 units foreign) |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102004 | ENDEAVOUR MONITORING SYSTEM Mindray DS USA, Inc., Sep 10, 2010 |