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Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary… recallZ-2866-2016 · Sorin Group USA, Inc. · initiated Aug 25, 2016

Class II Terminated All recalls posted in September 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sorin Group USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-2866-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 25, 2016
Posted by the FDA
Sep 21, 2016
Recalling firm
Sorin Group USA, Inc.
Quantity
5264 Units Worldwide
Product code
DTQ
FDA submissions
K071318
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

22 devices cleared under K071318 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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