Recall Z-1154-2014 ยท HKI Camera, Ophthalmic, Ac-Powered
Clarity Medical Systems Inc
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
| Date | Mar 7, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Urgent Safety Alert letters were sent to Risk Manager and to NICU US consignees via FedEx on 1/24/2014. Template of letters to OUS distributors to be sent on distributors letterhead and sent to device recipients via electronic communication and./or hard copy on 1/24/2014. |
| Quantity | 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables. |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, C |
| FDA record | Open on fda.gov |