Oculus recalls Pentacam AXL Model 70100 with specific software versions due to potential incorrect quality specification markings in eye scans. Affected units have serial numbers listed in the notice.
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Oculus is recalling certain versions of its Pentacam AXL eye scanning device software. The issue could lead to inaccurate eye quality measurements, which might affect medical decisions. Users should check if their device matches the described software versions and serial numbers.
The software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13 may produce incorrect quality specification values during eye scans. This could lead to inaccurate measurements of corneal shape, lens condition, or other eye structures, potentially affecting medical decisions.
Medical professionals using the Pentacam AXL for eye examinations are most likely affected. Patients using the device for diagnostic purposes may also be impacted if the software error affects their eye scan results.
Check if your Pentacam AXL has the model number 70100 and software versions 1.21r01, 1.21r03, 1.21r11, or 1.21r13. The serial numbers listed in the recall notice are specific to affected units.
Look for the software version on your device to see if it matches the recalled versions (1.21r01, 1.21r03, 1.21r11, or 1.21r13).
Check the serial number on your device against the list of affected serial numbers provided in the recall notice.
Software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13 are affected.
Check your device's software version and serial number against the list of affected versions and serial numbers provided in the recall notice.
The recall notice does not mention a specific fix or remedy for this software issue.
We’ve drafted a message you can send Oculus to request your refund or repair — edit it as you like.
Subject: Recall Z-0635-2018 — Oculus Oculus Hello, I own a Oculus that is covered by recall Z-0635-2018 from Oculus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
