CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report
CARINAsim Man-1236 Rev 2 and CARINAiso Man-1237 Rev 2 laser recalled
LAP of America Laser Applications is recalling CARINAsim MAN-1236, distributed in 36 states. The recall was initiated on 7 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1709-2014
- FDA event ID
- 68266
- Recalling firm
- LAP of America Laser Applications, Boynton Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2013
- FDA classified
- 3 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 7 Oct 2013 | Recall initiated by company | |
| 3 Jun 2014 | Classified by FDA | +239 days |
| 11 Jun 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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)
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
Where it was distributed
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.
AlaskaArizonaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNew Hampshire
Questions about this recall
Why was it 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)
Which lots are affected?
CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LAP of America Laser Applications
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lap Laser Pictor 3D Multi Color Laser System Pictor 3D recalled | LAP of America Laser Applications | Other | NC |
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| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |