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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Event Detail

Event ID 68266
Product Type Devices
Status Ongoing
Recalling Firm LAP of America Laser Applications, LLC
City Boynton Beach
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-07
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment. CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002 Class II 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 2 / CARINAiso MAN-1237 Rev 2) 280 Manuals Z-1709-2014