Mindray DS USA — Class II medical device recall Z-0798-2013
Terminated recall by Mindray DS USA, Inc. d.b.a. Mindray North America, reported 2013-02-20, distributed nationwide. Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG wav
| Recall number | Z-0798-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2012-11-28 |
| Classified | 2013-02-11 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 51 units |
| Reason classes | software |
| Serial numbers | 115-006908-04, 300BF-PA00002, 300BF-PA00003, EH-11000052, EH-12000054, EH-12000060, EH-12000062, EH-13000078, EH-13000085, EH-16000029, EH-17000031, EH-17000032, EH-17000033, EH-17000036, EH-17000037, EH-17000038, EH-17000039, EH-17000040, EH-18000043, EH-18000050, EH-18000051, EH-18000053, EH-18000054, EH-18000058, EH-19000059 and 10 more |
| Model numbers | 300BF-PA00002, 300BF-PA00003 |
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 Central station and other networked devices.
Reason for recall
Mindray has identified a software anomaly that may where, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0798-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.