RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. Gener
FDA device recall Z-1154-2014 · posted 2014-03-07 · Terminated
Recall details
- Recalling firm
- Clarity Medical Systems Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- HKI
- Quantity affected
- 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 countr
- Date initiated
- 2014-01-24
- Date posted
- 2014-03-07
- Date terminated
- 2014-08-11
- Location
- Pleasanton, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RETCAM 3 OPTHALMIC IMAGING SYSTEM (K102859) | Clarity Medical Systems | 2011-04-20 |
| RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS (K090326) | Clarity Medical Systems | 2009-11-25 |
| RETCAM 3 OPHTHALMIC IMAGING SYSTEM (K081858) | Clarity Medical Systems | 2008-11-05 |