Recall Z-2866-2016 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sorin Group USA, Inc.
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.
| Date | Sep 21, 2016 (initiated Aug 25, 2016) |
| Status | Terminated |
| Reason | 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 | Employee error |
| Action | 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. |
| Quantity | 5264 Units Worldwide |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Jul 6, 2007 |