Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number
FDA device recall Z-1675-2015 · posted 2015-05-26 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and Panorama will not be displayed on the Panorama following a restart of either system (due to communication loss, restart, etc.).
- Action taken
- Mindray sent a Corrective Action letter dated March 12, 2015 to their affected customer via FedEx. The letter identified the affected product, problem and actions to be taken. For questions call 201-995-8407.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 4 units
- Distribution
- Worldwide Distribution - US Nationwide in the state of TX.
- Date initiated
- 2015-03-12
- Date posted
- 2015-05-26
- Date terminated
- 2017-03-28
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Panorama Patient Monitoring Network (K142601) | Shenzhen Mindray Bio-Medical Electronics Co. | 2014-11-14 |