Mindray V-Series Patient Monitor Recalled for Drug Calculator Function Issue
Mindray DS USA is voluntarily recalling V-Series Patient Monitors due to a software issue with the Drug Calculator function.
What this means for you
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 a voluntary field corrective action for a software function issue with no reported injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America has initiated a voluntary field corrective action for the Mindray V-Series Patient Monitor. The recall is due to an issue with the V-Series Drug Calculator function.
The affected product is the Mindray V21 monitor, which is intended for intra-hospital use under the direct supervision of a licensed healthcare practitioner. The device monitors various patient parameters, including ECG, heart rate, pulse oximetry, and blood pressure. A total of 2,247 units are involved in this recall.
Distribution of the affected units was worldwide, including the United States and international locations such as Australia, Canada, Germany, India, and the United Kingdom. Healthcare facilities and users should contact Mindray DS USA for instructions on the corrective action.
The recalled product
- Product
- 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 hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 2,247
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 (3)
- V-Series Monitoring System
- P/N: 0998-00-1800-101
- 0998-00-1800-201 and DA6KB-CTO-S01.
Distribution
Distributed nationwide across the United States.
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