Aug

2015

Cl II BIOTRONIK Pacemaker Programmer software

Company: BIOTRONIK Inc..
Date of Enforcement Report 8/19/2015
Class lI:

PRODUCT

PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. Recall Number Z-2376-2015

REASON
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.

RECALLING FIRM/MANUFACTURER
BIOTRONIK, Inc., Lake Oswego, OR on 6/30/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
768 units (software)

DISTRIBUTION
Nationwide

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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 II BIOTRONIK Pacemaker Programmer software

Amy Sellers

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