Z-1709-2014 Class II Terminated
FDA device recall Z-1709-2014 was initiated by LAP of America Laser Applications, LLC on October 7, 2013 and is designated Class II. Reason for recall: Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev … The recall status is terminated (terminated September 14, 2016). Affected quantity: 280 Manuals.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2014
- Initiation Date
- October 7, 2013
- Termination Date
- September 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 Manuals
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -- USA, including the states of AK, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WY and the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.