Apr

2014

TDWorkstation Cl III

Company Spacelabs Healthcare, Llc.
Date of Enforcement Report:4/9/2014
Class lII:

PRODUCT

TDWorkstation version 11.01.A or higher. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
Recall Number Z-1310-2014

REASON
If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.

RECALLING FIRM/MANUFACTURER
Technidata S.A., Montbonnot St Martin on.2/17/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
85 units total (1 unit in US)

DISTRIBUTION
State of PA

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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TDWorkstation Cl III

Amy Sellers

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