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Recall Observatory FDA recall evidence

Device product

LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.

Z-1615-2024

March 18, 2024

Class II

Product summary

Firm
XENEX Disinfection Services Inc.
Event
Event 94258
Status
Ongoing
Classification
Class II
Quantity
377
Official record key
device-enforcement:Z-1615-2024

Official wording

Reason: Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.

Code information: Robot UDI-DIs: 00814122020033, 00814122020064, 00814122020125, 00814122020132. All serial numbers.

Distribution pattern: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, ID, IL, KY, LA, MI, MN, MO, NC, ND, NV, OH, OK, OR, TN, UT, WA, WV, WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.