Jan

2010

Cl Il Hocoma Lokomat-System with Pediatric Module

Company:Hocoma AG,br>Date of Enforcement Report 1/27/2010
Class:ll

PRODUCT
Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. Recall # Z-0590-2010

REASON
Changes to the stored “sensitivity” values may occur and leads to higher limits in the force and trajectory deviation.p>

RECALLING FIRM/MANUFACTURER
Hocoma AG, Zuerich, Switzerland, by letter dated May 27, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 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 Il Hocoma Lokomat-System with Pediatric Module

Amy Sellers

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