Sep

2008

Cl Il Stryker Digital Capture System Ultra

Company: Stryker Endoscopy
Date of Enforcement Report 9/17/2008
Class:ll

PRODUCT
Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system, Recall # Z-1316-2008

REASON
Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.

RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letters dated February 14, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
814 units

DISTRIBUTION
Nationwide and Internationally

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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Cl Il Stryker Digital Capture System Ultra

Amy Sellers

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