Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
FDA device recall Z-1104-05 · posted 2005-08-06 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
- Action taken
- The firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRT
- Quantity affected
- 70 units
- Distribution
- There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
- Date initiated
- 2005-06-16
- Date posted
- 2005-08-06
- Date terminated
- 2005-10-05
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |