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CARINAiso and CARINAsim Laser Marking System (2013-11-08)
- Starting date:
- November 8, 2013
- Posting date:
- June 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40041
Recalled Products
A) CARINAiso Laser Marking System
B) CARINAsim Laser Marking Software
Reason
There is a 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)
Affected products
A) CARINAiso Laser Marking System
Lot or serial number
CARINAiso.1.1.3.MAN-1237Ver2.0
Model or catalog number
COM-00115
Companies
- Manufacturer
-
LAP GMBH
ZEPPELINSTRASSE 23
LUNEBURG, GERMANY
21337
B) CARINAsim Laser Marking Software
Lot or serial number
CARINAsim.1.1.3.MAN-1237Ver2.0
Model or catalog number
COM-00126
Companies
- Manufacturer
-
LAP GMBH
ZEPPELINSTRASSE 23
LUNEBURG, GERMANY
21337