Recall Z-0160-2011 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Edwards Lifesciences, Llc
Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
| Date | Oct 28, 2010 (initiated Jun 25, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated. |
| Root cause | Process design |
| Action | Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060660 | EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER Edwards Lifesciences, LLC, Apr 25, 2006 |