Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascop
FDA device recall Z-1401-2009 · posted 2009-05-27 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Reason for recall
- Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.
- Action taken
- Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 294 sites
- Distribution
- Worldwide Distribution -- USA and Australia.
- Date initiated
- 2009-04-10
- Date posted
- 2009-05-27
- Date terminated
- 2010-08-03
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |