Covidien Valleylab FT10 Energy Platform software issue causes inoperability
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
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 recall of a medical device with a software defect that may render systems inoperable. No reported illnesses, injuries, or deaths are mentioned in the source. The potential for harm exists if the device malfunctions during use, but no actual adverse events have been reported.
Plain-English summary
Covidien is recalling 47,901 units of the Valleylab FT10, FT Series Energy Platform devices. The recalled devices are identified by REF numbers VLFT10GEN, DLVLFT10GEN, and VLFT10GENZD, running software versions 4.0.1, 4.0.2, or 4.0.3.
A software issue in these devices may cause new systems to exhibit an error that prohibits their use, resulting in system inoperability.
The devices have been distributed worldwide, including throughout the United States and surrounding territories.
The recalled product
- Product
- Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
- Manufacturer
- Covidien
- Category
- Medical Device
- Affected units
- 47,901
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)
- Ref-UDI: VLFT10GEN- 10884521516328
- DLVLFT10GEN - 10884521787056
- VLFT10GENZD - 10884521640474/Software: v4.0.1
- v4.0.2 and v4.0.3
Distribution
Distributed nationwide across the United States.
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