Reported Jun 11, 2014 · Terminated
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser…
Lap of America Laser Applications, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LAP of America Laser Applications, LLC · 161 Commerce Rd Ste 3 · Boynton Beach, FL · 33426-9385
Is this the product you have?
- CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
- Lot codes and dates
- CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
- Amount recalled
- 280 Manuals
Where it was sold
Why it was 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)
This product could cause temporary or reversible health problems — stop using it.
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