Mindray Recalls V Series Patient Monitors Due to Touchscreen Malfunction
Mindray is recalling V Series patient monitors because the touchscreens may stop responding to touch.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Mindray DS USA, Inc. d.b.a. Mindray North America is recalling the V Series Monitor, a multi-parameter patient monitor used in hospitals. The recall involves 206 units, including 180 units distributed domestically and 26 units distributed internationally to Great Britain, Colombia, and Australia.
The recall was initiated because the monitors' touchscreens may stop responding to touch. The affected devices are the V12 and V21 models, which monitor physiological parameters such as ECG, heart rate, and blood pressure. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities should contact Mindray for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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…
- Category
- Medical Device — Patient Monitor
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.
Distribution
Distributed nationwide across the United States.
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