Z-1709-2014 Class II Terminated
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
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
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 2 / CARINAiso MAN-1237 Rev 2)
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.
Code Information
CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002