Mindray DPM Central Station Recalled for Patient Data Anomaly
Mindray is recalling two DPM Central Station units due to a software anomaly that may replace one patient's trend data with another's.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Mindray DS USA, Inc. is recalling two units of the DPM Central Station. The device is a medical monitoring system used in hospitals and medical institutions for remote monitor management and data processing.
The recall is due to a software anomaly where the trend data of one patient may be replaced with the trend data of a second patient. This error could result in medical personnel reviewing incorrect patient information.
The affected units were distributed nationwide, including Ohio and Georgia. The source text does not specify instructions for consumers or end-users regarding the recall.
The recalled product
- Product
- DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network…
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)
- 510 K K080192 P/N 300BF-PA200002
Distribution
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