CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 recall
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
Why was CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 recalled?
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)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
- Product
- CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
- Recalling firm
- LAP of America Laser Applications, LLC
- Quantity
- 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.
- Recall date
- June 11, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)