FDA Medical Device Recalls (openFDA)
Inlightened Partners LLC: inLight Medical LED Pads used with Polychromatic light technology system
- Recall number
- Z-1943-2021
- Recalling firm
- Inlightened Partners LLC
- Product
- inLight Medical LED Pads used with Polychromatic light technology system
- Status
- Terminated
- Initiated
- 2019-06-04
- Posted
- not on file
- Terminated
- 2021-06-25
- 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.
- Lot, serial or model codes
- All serial numbers with cord connectors that have v-shaped notches
- 510(k) numbers
- ["K153389"]
- PMA numbers
- not on file
- Product code
- ILY
- Firm FEI
- 3010709091
- Firm city
- Addison
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28