Recall Z-1943-2021 ยท ILY Lamp, Infrared, Therapeutic Heating
Inlightened Partners LLC
inLight Medical LED Pads used with Polychromatic light technology system
| Date | Jun 4, 2019 |
| Status | Terminated |
| Reason | LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down. |
| Root cause | Component change control |
| Action | On 6/5/2019, Medical Device Recall Letters were emailed to customers. Customers were instructed to examine the connector on the cord attached to their pad and compare it to photos provided in the Medical Device Recall Letter. The connectors for recalled product contain a v-shaped notch. Customers in possession of a pad with the connector matching the photos were requested to complete an Acknowledgement and Receipt Form. Customers with questions were asked to call Customer Service at 1-800-455-4116. |
| Quantity | 926 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, TX, NC, ID, CO, VA, FL, VT, AK, DC, MA, IL, AZ, MN, IA, TN, WI, WA, OK, MI, OH, GA, NY, IN, PA, NV, NJ, AR, CO , LA, MT, OR, SD, ND, MD, UT, MO, KY, NM, KS, AS, NE, WY, PR, MS and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) In Light Wellness Systems, Inc., Mar 30, 2016 |