Mindray Recalls V Series Patient Monitors Due to Software Anomalies
Mindray is recalling 979 V Series Patient Monitors worldwide due to two identified software anomalies. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the product is a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Mindray DS USA, Inc. is recalling 979 units of the V Series Patient Monitor. The recall is due to two software anomalies identified in the monitoring system. The affected units were distributed between September 31, 2010, and January 9, 2012.
The V Series Monitor is intended for intra-hospital use under the direct supervision of a licensed healthcare practitioner. It monitors various physiological parameters, including ECG, heart rate, pulse oximetry, and blood pressure. The target populations include adults, pediatrics, and neonates, with specific limitations for certain functions like arrhythmia detection and cardiac output.
The recall covers units distributed in the United States (including specific states and Puerto Rico) and internationally in Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom, and Venezuela. Mindray has stated that there have been no reports of injuries associated with these anomalies.
The recalled product
- Product
- V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human ph
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 979
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 Part Numbers 0998-00-1800-101 and 0998-00-1800-201.
Distribution
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