Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra h
FDA device recall Z-0107-2015 · posted 2014-10-21 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.
- Action taken
- Mindray DS USA, Inc. sent a Recall Correction Action Letter to their customers via certified mail with return receipt on July 31, 2014.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 2,247 units
- Distribution
- Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation, Sau
- Date initiated
- 2014-07-31
- Date posted
- 2014-10-21
- Date terminated
- 2017-04-20
- 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 |
|---|---|---|
| V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 (K132026) | Mindray DS USA, Inc. | 2013-12-20 |