Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
FDA device recall Z-0437-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
- Action taken
- Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 110 sites
- Distribution
- The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.
- Date initiated
- 2005-12-07
- Date posted
- 2006-01-24
- Date terminated
- 2006-08-01
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |