Food, drugs, devices › Mindray DS USA, Inc. d.b.a. Mindray North America
Device recall: 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 enforcement event 63652 is a device recall by Mindray DS USA, Inc. d.b.a. Mindray North America of Mahwah, NJ, initiated 24 Sep 2012 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 15 Aug 2013. Initiation: voluntary: firm initiated. Mindray DS USA, Inc. d.b.a. Mindray North America has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ.
Reason for recall
"Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch."
Distribution
"Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0528-2013 | 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… | 206 units (180 units domestic, 26 units foreign) | Class II | Terminated | 26 Dec 2012 |
Context
Other enforcement events for Mindray DS USA, Inc. d.b.a. Mindray North America
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Nov 2012 | BS-200 Chemistry Analyzer Designed for clinical laboratory use. | Device | Class II | 1 |
| 28 Nov 2012 | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA0 | Device | Class II | 1 |
| 5 Sep 2012 | Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. | Device | Class II | 1 |
| 13 Aug 2012 | Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ | Device | Class I | 2 |
| 7 May 2012 | V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use u | Device | Class II | 1 |
| 12 May 2011 | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) | Device | Class II | 1 |
| 11 Aug 2010 | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Inten | Device | Class II | 1 |
All 8 events for Mindray DS USA, Inc. d.b.a. Mindray North America
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Aug 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.