Ultraview Universal Clinical Workstation Model 90385.
FDA device recall Z-1007-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Spacelabs Medical Inc.
- Reason for recall
- Potential for telemetry channels to drop off display.
- Action taken
- For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 142 units
- Distribution
- The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.
- Date initiated
- 2004-05-07
- Date posted
- 2004-07-20
- Date terminated
- 2006-04-08
- Location
- Issaquah, WA
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