Recall Z-1709-2014— LAP of America Laser Applications, LLC
Class II · Terminated
Class II FDA medical device recall by LAP of America Laser Applications, LLC, initiated 2013-10-07, terminated 2016-09-14. FDA's recall record names no specific 510(k) clearance for this event. Product: CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.. Reason: 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).
- Recalling firm
- LAP of America Laser Applications, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-07
- Terminated
- 2016-09-14
- Firm location
- Boynton Beach, FL, United States
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.