LAP Laser Software Recall Due to Incorrect Patient Marking Instructions
LAP of America is recalling CARINAsim and CARINAiso laser software manuals due to errors that may cause incorrect patient marking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where the hazard is incorrect patient marking, but no injuries or illnesses have been reported in the source text.
Plain-English summary
LAP of America Laser Applications, LLC is recalling 280 manuals for the CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. These manuals serve as operating instructions for laser systems used for patient alignment.
The recall was initiated because the operating instructions contain two safety-relevant errors. These errors create a potential for patients to be marked incorrectly during the alignment process.
The affected manuals were distributed worldwide, including in the United States and several countries in the Americas. Customers currently using the CARINAsim or CARINAiso systems should review the recall notice for specific instructions on how to address the errors in the operating instructions.
The recalled product
- Product
- CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
- Manufacturer
- LAP of America Laser Applications, LLC
- Category
- Medical Device — Laser Software
- Hazard
- Affected units
- 280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
Distribution
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