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Terminated

Ultraview Universal Clinical Workstation Model 90385.

FDA Recall Z-1007-04 · Posted 2004-07-20

Recalling FirmSpacelabs Medical Inc.
Recall StatusTerminated
Product CodeDSI
Date Initiated2004-05-07
Date Terminated2006-04-08
Product Quantity142 units

Reason for Recall

Potential for telemetry channels to drop off display.

Firm Action

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

Distribution Pattern

The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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