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
FDA device recall Z-0528-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Reason for recall
- Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 206 units (180 units domestic, 26 units foreign)
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
- Date initiated
- 2012-09-24
- Date posted
- 2012-12-17
- Date terminated
- 2013-08-15
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDEAVOUR MONITORING SYSTEM (K102004) | Mindray DS USA, Inc. | 2010-09-10 |