Tissue oximeter module may provide inaccurately low oxygen readings
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. However, inaccurate tissue oxygen readings could lead to inappropriate clinical treatment decisions, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling 8,389 units of the FORE-SIGHT ELITE Tissue Oximeter module (Model HEMFSM10), a medical device used to monitor tissue oxygen saturation levels. The recalled devices were distributed worldwide, including throughout the United States and to numerous countries internationally.
The tissue oximeter module may display inaccurately low oxygen saturation values when using the large sensor in certain body locations, particularly the arms and legs. While the direction of oxygen level changes remains accurate, the magnitude of those changes may be larger than actual. Healthcare providers should be aware that these inaccurate readings could result in unintended or inappropriate treatment decisions.
The recalled product
- Product
- FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Tissue Oximeter
- Affected units
- 8,389
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- FORE-SIGHT ELITE Tissue Oximeter module
- REF: HEMFSM10
- UDI: 00690103208573
- All serial numbers.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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