12
Aug
1998

Cyberonic Prosthesis Programming SW Class II

0

8/12/98 Class II

PRODUCT

Model No. 250 NeuroCybernetic Prosthesis Programming (NCP)

Software, Version 5.0 for use only with the Model No. 100

NCP Pulse Generator and Model No. 200 NCP Programming Wand,
an implanted autonomic nerve stimulator implanted for epilepsy. Recall #Z-492-0.

REASON

The software contains a flaw that reports an inaccurate amount of remaining battery life for the pulse
generator.

CODE

All lots.

MANUFACTURER

Cyberonics, Inc., Houston, Texas.

RECALLED BY

Manufacturer, by memorandum on August 12, 1998. Firm-initiated field correction complete.

DISTRIBUTION

Nationwide, South Africa, Belgium.

QUANTITY

402 units were distributed; firm estimates none remains on the market.

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.

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