Atlas FDA

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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