Z-0835-2022Class II

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Name: Z-0835-2022 FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Creator: Edwards Lifesciences, LLC
Published: 2022-03-01
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2022-03-01 / Open, Classified / root cause: software

FDA source

Edwards Lifesciences, LLC began a recall of FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 on 2022-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0835-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-01
Posted: 2022-03-30
Recalling firm: Edwards Lifesciences LLC
Product: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Product code: MUD Oximeter, Tissue Saturation
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
Root cause tag: software
FDA 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 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 [email protected], 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 [email protected] 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 [email protected]. 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 commerce: 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, 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.
Product codes and lots: FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0835-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0834-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-30
Z-0835-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-30

Product code MUD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)