FDANovember 21, 2017device
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, a...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
What to do
FDA enforcement status: Terminated
Brands named
oculus optikgeraeteoculus
UPCs
701000021619070100030151707010003116150701000331713070100040151017010004216101701000641717070100083171507010010216190701001101517070100154171707010016317140
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPhaseOne Antimicrobial Solution, Model/Catalog Number: 150502026-04-27
- FDAOculus Pentacam AXL Wave, Ref 70020, CE 01232023-08-08
- FDAOculus Pentacam AXL , Ref 70100, CE 01232023-08-08
- FDAOculus Myopia Master , Ref 68100, CE 01232023-08-08
- FDAPentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.2022-07-08
- FDAPentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.2022-07-08
- FDAPentacam HR REF 70900. Used to image the anterior segment of the eye.2022-07-08
- FDACeramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses incl...2016-11-21
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