Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA0
FDA device recall Z-0798-2013 · posted 2013-02-11 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America
- 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.
- Action taken
- Mindray North America/ Mindray DS USA Inc. sent an "URGENT PRODUCT CORRECTION ACTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your Mindray Service Representative at 1-800-288-2121 for questions relating to this issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 51 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-11-28
- Date posted
- 2013-02-11
- Date terminated
- 2013-08-15
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) (K080192) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-04-03 |