Z-1104-05
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor
Datascope Corp. / initiated 2005-06-16 / Terminated / root cause: software
Datascope Corp began a recall of Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor on . The reason FDA records is "Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1104-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Datascope Corp.
- Product
- Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
- Product code
- DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- 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.
- Root cause tag
- software
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 70 units
- Distribution
- There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.
- Product codes and lots
- All units currently out in the market.
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