Mindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly
Mindray is recalling 51 DPM Central Monitoring Systems because a software anomaly may display a step pattern instead of a flat line during asystole.
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 is classified as FDA Class II, and the hazard involves a medical device that monitors critical cardiac data. While no injuries are reported, the potential for misinterpretation of asystole constitutes a risk of harm.
Plain-English summary
Mindray DS USA, Inc. is recalling 51 units of the DPM Central Monitoring System with ambulatory Telepack. The affected units include specific part numbers 300BF-PA00002 and 300BF-PA00003, as well as DPM software upgrade kits with part numbers 115-006908-01, -03, and -04. The devices were distributed nationwide.
The recall was initiated due to a software anomaly. In the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern instead of a flat line if Lead 1 or V is being utilized for detecting cardiac arrhythmia. This display error could potentially affect the visual interpretation of the patient's cardiac status.
Healthcare facilities and users should check their inventory for the specific part and serial numbers listed in the recall notice. Mindray has identified the issue and is managing the recall to address the software defect.
The recalled product
- Product
- Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM…
- Affected units
- 51
Distribution
Distributed nationwide across the United States.
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