Recall Z-2866-2016— Sorin Group USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2016-08-25, terminated 2017-05-26. It names one FDA 510(k) clearance: K071318. Product: St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert 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.. 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..
- Recalling firm
- Sorin Group USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-25
- Terminated
- 2017-05-26
- Firm location
- Arvada, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert 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.
Reason for recall
Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
Data sourced from openFDA. This site is unofficial and independent of the FDA.