Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1709-2014 — CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

U.S. FDA — Device Enforcement · United States · 2013-10-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1709-2014
Date of alert: 2013-10-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: LAP of America Laser Applications, LLC
Product category: device
Product type: Devices

Reported risk: 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)

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1709-2014 — CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

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