Z-1943-2021Class III

inLight Medical LED Pads used with Polychromatic light technology system

Name: Z-1943-2021 inLight Medical LED Pads used with Polychromatic light technology system
Creator: Inlightened Partners LLC
Published: 2019-06-04
License: https://open.fda.gov/license/

In Light Therapy, Inc. / initiated 2019-06-04 / Terminated

FDA source

Inlightened Partners LLC began a recall of inLight Medical LED Pads used with Polychromatic light technology system on 2019-06-04. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1943-2021
Classification: Class III
Status: Terminated
Initiated: 2019-06-04
Posted: 2021-06-24
Terminated: 2021-06-25
Recalling firm: In Light Therapy, Inc.
Product: inLight Medical LED Pads used with Polychromatic light technology system
Product code: ILY Lamp, Infrared, Therapeutic Heating
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers with cord connectors that have v-shaped notches

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1943-2021	Class III	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24

Product code ILY

K153389Class IIElysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc. / cleared 2016-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)