Ultraview Universal Clinical Workstation System Model 90385.
FDA Recall Z-0422-05 · Posted 2005-01-25
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Recalling FirmSpacelabs Medical Incorporated
Recall StatusTerminated
Product CodeDXJ
Date Initiated2005-01-07
Date Terminated2011-01-17
Product Quantity12,306 devices with this base style.
Reason for Recall
Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
Firm Action
All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.
Root Cause
Other
Distribution Pattern
The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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