NeuroCybernetic Prostheses Software Class II

PRODUCT

Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions

a) 4/1;

b) 4.4, implanted autonomic nerve stimulator for he treatment of
epilepsy.

REASON

The label insert sheets were printed with the incorrect lot number.

CODE

Lot numbers a) 23952C; b) 26023C, 27137C, 27735C.

Recall #Z-570/571-0.

MANFACTURER

Cyberonics, Inc., Inc., Houston, Texas.

RECALLED BY

Manufacturer, by telephone and letter on August October 6, 1999. Firm-
initiated field correction complete.

DISTRIBUTION

a) Canada; b) Belgium and Europe.

QUANTITY

a) 1 unit of lot number 23952C; b) 10 units of lot number, 26023C, 10
units of lot 27137C and 50 units of lot 27735C were distributed.

About the author

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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