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Class 2 Device Recall CARINAsim and CARINAiso |
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Date Initiated by Firm |
October 07, 2013 |
Date Posted |
June 03, 2014 |
Recall Status1 |
Terminated 3 on September 14, 2016 |
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 FL 33426-9385
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For Additional Information Contact |
Tom Gaudet 561-416-9250
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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)
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FDA Determined Cause 2 |
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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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