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Recall Observatory FDA recall evidence

Device product

Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

Z-0797-2019

April 04, 2018

Class II

Product summary

Firm
Handpiece Headquarters
Event
Event 81459
Status
Ongoing
Classification
Class II
Quantity
252 curing lights (rec'd by recalling firm; 142 were further dist)
Official record key
device-enforcement:Z-0797-2019

Official wording

Reason: Tip of the curing light was too hot causing a heat sensation in the patients.

Code information: Serial #17C0001 to #17C0252

Distribution pattern: Worldwide distribution including US nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and to Guam. There was also military/government distribution, and countries of Johannesburg, Panama, Suriname, and Trinidad.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tip of the curing light was too hot causing a heat sensation in the patients.