Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors
Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.
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 medical device with a risk of harm due to incorrect diagnostic information (false measurements and incorrect interpretive statements), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mindray DS USA, Inc. is recalling 113 units of the V-Series Patient Monitoring System. The recall affects 57 units in the United States and 56 units internationally. The devices are used for monitoring human physiological parameters, performing IV drug and hemodynamic calculations, and interfacing with network devices.
The recall is due to issues with the ECG interpretation feature. The algorithm may report false measurements when it cannot determine the P wave or QRS axis. Additionally, the Median Complex Report displays the representative beat 25% larger than the actual signal input. When a patient's date of birth is imported from an external source, the algorithm defaults to an age of 50, which may result in incorrect interpretive statements.
The affected units are identified by Part Numbers 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Modules (P/N: 0998-00-1804-01 and 0998-00-1804-02). The devices were distributed worldwide, including in the US states of Louisiana, New Jersey, Montana, South Carolina, and Wyoming. Healthcare facilities should contact Mindray for instructions on how to address the software issues.
The recalled product
- Product
- V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
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)
- P/N:0998-00-1804-01 and 0998-00-1804-02.
Distribution
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