Recall Z-0835-2022 ยท MUD Oximeter, Tissue Saturation
Edwards Lifesciences, LLC
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
| Date | Mar 1, 2022 |
| Status | Open, Classified |
| Reason | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment |
| Root cause | Software in the Use Environment |
| Action | Urgent Medical Device Correction communication dated March 01, 2022 was sent via FedEx 2nd Day Advice on action to be taken by user: Customers are to refrain from using the large sensors on certain somatic locations (arms and legs). Cerebral and flank/abdomen locations for the large sensors are not impacted. Instructions for customers: " Review the customer letter for advice on how to use impacted product. " Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process. " Do not return any product. " Distribute this notice within your |
| Quantity | 8389 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, |
| FDA record | Open on fda.gov |