LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the e
Check against the official notice below — it lists the full affected range.
The LipiFlow Thermal Pulsation System, a prescription medical device used by physicians, has been recalled due to an error condition that causes the system to automatically stop treatment when it detects a problem with the Activator component. The issue affects 1,200 Activators (distributed in 120 boxes of 10 units) from Lot 201615220020 that were distributed across the United States, including Alaska, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Nevada, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Puerto Rico.
The recall notice does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Reason for recall: Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. Distribution: US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico. Quantity: 1,200 Activators (120 boxes of 10 units) Lot/code info: Lot 201615220020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.