Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S
FDA device recall Z-2866-2016 · posted 2016-09-21 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 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
- Date initiated
- 2016-08-25
- Date posted
- 2016-09-21
- Date terminated
- 2017-05-26
- Location
- Arvada, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: STOCKERT S5 SYSTEM (K071318) | Sorin Group Deutschland GmbH | 2007-07-06 |