—#149150

Product

Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071318
Affected lot / code info: Item No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670 Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679 Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664 Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656

Why it was recalled

Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.

Root cause (FDA determination)

Employee error

Action the firm took

Sorin Group Deutschland GmbH created Field Correction Order (FCO) 2016-003 on August 11, 2016 to replace the affected power supply with a new unit. The customers will be contacted by the Field Service Representatives to schedule the replacement at the customer facilities. No direct action is required by the customer.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.

Timeline

Recall initiated: 2016-08-25
Posted by FDA: 2016-09-21
Terminated: 2017-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149150. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.