Summary
The FDA issued a Class II for SOZO Bilateral Arm L-Dex Software by Impedimed Limited. Reason: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex a.
Details
Source
Device Recall
External ID
Z-0155-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
SOZO Bilateral Arm L-Dex Software
Lot/Code Info: UDI-DI: B277SFT0250. Software v4.1 and v5.0
Quantity Affected: 354
Reason for Recall
Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.
Distribution
US Nationwide distribution in the states of IA, CA, IL, AK, NY, FL, KS, WI, MI, NC, GA, SD, KY, TX, MA, LA, AZ, RI, AR, CO, WY, OH, IN, MO, NJ, MD, CT, WA, PA, UT, VA, NM, ME, MN, DC, TN, NE, OR, ND, WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-17
Company
Pinkenba, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Impedimed Limited has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Impedimed Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Impedimed Limited have FDA actions?
Impedimed Limited has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0155-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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