Z-1943-2021 Class III Terminated
FDA device recall Z-1943-2021 was initiated by Inlightened Partners LLC on June 4, 2019 and is designated Class III. 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. The recall status is terminated (terminated June 25, 2021). Affected quantity: 926.
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- June 4, 2019
- Termination Date
- June 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 926
Product Description
inLight Medical LED Pads used with Polychromatic light technology system
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.
Distribution Pattern
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.
Code Information
All serial numbers with cord connectors that have v-shaped notches