Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
FDA device recall Z-1567-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
- Action taken
- A recall letter was sent to the consignees on 8/19/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRT
- Quantity affected
- 115 units
- Distribution
- The affected software was distributed to 108 domestic sites and seven international sites. There are no sale of affected Panorama software to the US Govt.
- Date initiated
- 2005-08-19
- Date posted
- 2005-09-21
- Date terminated
- 2006-06-21
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |