Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall FORESIGHT ELITE Absolute Tissue Oximeter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall FORESIGHT ELITE Absolute Tissue Oximetersee related information
Date Initiated by FirmMarch 01, 2022
Create DateMarch 30, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0834-2022
Recall Event ID 89647
510(K)NumberK143675 K203490 
Product Classification Oximeter, tissue saturation - Product Code MUD
ProductFORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Code Information FORE-SIGHT ELITE Tissue Oximeter, Model Number 01-06-3000, UDI: 10609538630009; All Serial numbers.
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information ContactLinnette Torres
949-756-4582
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Software in the Use Environment
ActionUrgent 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 organization or to any organization where the potentially impacted product has been transferred. " Verify your inventory. " E-mail the completed form to Edwards Technical Support at tech_support@edwards.com, within 15 days from receipt of this notification. Advice on action to be taken by Distributor: Please review this letter and complete the acknowledgement form. Return the acknowledgement form to tech_support@edwards.com within 15 days of receipt of this notification. Please forward this customer communication to any of your customers who have purchased the impacted Edwards product. If you still have product within your control, please do not distribute impacted product to any customers. You can call Edwards Tech Support for instructions for handling product still within your control. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product from you and Edwards will communicate directly with your customers to facilitate the correction and acknowledgement process. Please forward your customer list to tech_support@edwards.com. If you have any questions, please contact Edwards Tech Support at 1 (800)-822-9837 If you have questions, contact Edwards Tech Support at 1 (800)-822-9837 from 5:00AM--4:30PM PST.
Quantity in Commerce402 units
DistributionWorldwide 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, Australia, Austria, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, CANARY ISLANDS, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Northern Ireland, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUD
510(K)s with Product Code = MUD
-
-