Feb

2004

GVI Technology Partner Class III

Company: GVI Technology Partner
Date of Enforcement Report: 2/18/04
Class: III

PRODUCT
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA. Recall # Z-0527-04.

REASON
Due to limitations in the operating software, the acquired scan may not be processed properly.

CODE
S/Ns: 100 thru 105, and 107 thru 116.

RECALLING FIRM/MANUFACTURER
GVI Technology Partners, Twinsburg, OH, by letter on January 16, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16 units.

DISTRIBUTION
PA, OH, FL, and SC.

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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GVI Technology Partner Class III

Amy Sellers

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