Sep

2010

Cl ll Sorin Paradym

Company: Sorin Biomedica C.R.M
Date of Enforcement Report 9/29//2010
Class ll:

PRODUCT
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Recall # Z-2579-2010

REASON
The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occur under a specific sequence of events.

RECALLING FIRM/MANUFACTURER
Recalling Firm: ela Medical LLC, Plymouth, MN, by letter dated June 7, 2010.
Manufacturer: Sorin Biomedica C.R.M., S.r.l., Saluggia, VC, Italy. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
215 units

DISTRIBUTION
Nationwide

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 ll Sorin Paradym

Amy Sellers

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