RetCam ShuttleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00864222000411), received between Feb 1, 2022 and Feb 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K090326); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022No Display/Image; Misfocusing; Connection Problem; No Display/Image; Misfocusing; Connection Problem

  ROHS COMPLIANT RETCAM SHUTTLE. THE CUSTOMER REPORTS THAT THE DEVICE FAILED IN THE MIDDLE OF AN EXAMINATION OF A (B)(6) CHILD, REQUIRING THE CUSTOMER TO GET ANOTHER DEVICE. THE IMAGES WERE NOT TRANSMITTED TO THE PEDIATRICIANS, FORCING THE CAREGIVER TO PHOTOGRAPH THE IMAGES WITH HIS PHONE, WHICH RESULTED IN LOSS OF IMAGE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090326. One submission often covers many models, so check the product and lot details in each record.

• Z-1154-2014 · Jan 24, 2014 · Terminated
  RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and exter
• Z-1099-2012 · Feb 2, 2012 · Terminated
  Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including re