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U.S. Department of Health and Human Services

Class 2 Device Recall CARINAsim and CARINAiso

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 Class 2 Recall
CARINAsim and CARINAiso
see related information
Date Posted June 03, 2014
Recall Status1 Open
Recall Number Z-1709-2014
Recall Event ID 68266
Product CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
Code Information CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
Recalling Firm/
Manufacturer
LAP of America Laser Applications, LLC
161 Commerce Rd Ste 3
Boynton Beach, Florida 33426-9385
For Additional Information Contact Tom Gaudet
561-416-9250
Manufacturer 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)
FDA Determined
Cause 2
DESIGN: Software Design
Action On 10/16/2013 Customers were sent an Urgent field safety notice for Corrective action concerning the operating instructions of CARINAsim and CARINAiso. The letter identified the affected product, as well as the issues involved. Users were to review their current operating steps and validate their operating sequence. Users should have received a modified software version with software update in February 2014. All users should have been notified of this letter and a copy should be maintained in the users' records. Questions should be directed to Thomas Gaudet on 561-416-9250 at the Service Center.
Quantity in Commerce 280 Manuals
Distribution 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.

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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