Recall Z-1265-2014 ยท HKI Camera, Ophthalmic, Ac-Powered
Clarity Medical Systems Inc
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
| Date | Mar 20, 2014 (initiated Mar 7, 2014) |
| Status | Terminated |
| Reason | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Clarity, sent a "Field Bulletin" dated March 12, 2014 to customers - risk managers and distributors by e-mail on March 12, 2014. They plan to follow this with a second letter on or about March 28, 2014 which will include a second bulletin, replacement bulbs and installation instructions. Clarity stated in the letter to its customers "In the meantime, you may continue to use your RetCAM 3." If you have any question of concerns, please contact Clarity at +1 925 621 322 or email to: service@retcam.com |
| Quantity | 234 lamps |
| Distribution | Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Kingdom, Philippines,The Netherlands, China,, UAE,Israel, Germany, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM Clarity Medical Systems, Nov 5, 2008 |