Mindray Recalls V Series Patient Monitors Due to Power Pin Issue
Mindray is recalling V Series Patient Monitors because power pins may lose tension, causing the screen to go blank or shut down.
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 3/5 (High).
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 involves a high-risk medical device where a functional failure (shutdown/loss of communication) poses a risk of harm, although the source explicitly states that no patient-related events have been reported.
Plain-English summary
Mindray DS USA, Inc. is recalling 1,839 units of the V Series Multi Parameter Patient Monitor. The recall involves the V Series Monitor (p/n 0998-00-1801-01) and the associated V Dock (p/n 0998-UC-180-01). These devices are intended for intra-hospital use under the direct supervision of a licensed healthcare practitioner.
The recall was initiated because the V Dock power pins connecting the monitor to the dock may lose spring tension. This issue can potentially cause the screen to temporarily go blank, lose communication with a central station monitor, or shut down. Mindray has stated that no patient-related events have been reported concerning this issue.
The affected units were distributed worldwide and nationwide in the USA. Healthcare facilities should contact Mindray for further instructions on how to address the defect.
The recalled product
- Product
- Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) 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…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,839
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 (2)
- V Series Montor p/n 0998-00-1801-01 and the associated V Dock
- p/n 0998-UC-180-01
Distribution
Distributed nationwide across the United States.
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