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