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Terminated

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.

FDA Recall Z-1154-2014 · Posted 2014-03-07

Recalling FirmClarity Medical Systems Inc
Recall StatusTerminated
Product CodeHKI
Date Initiated2014-01-24
Date Terminated2014-08-11
Product Quantity166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.

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.

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

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, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102859RETCAM 3 OPTHALMIC IMAGING SYSTEMClarity Medical Systems · 2011-04-20K090326RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMSClarity Medical Systems · 2009-11-25K081858RETCAM 3 OPHTHALMIC IMAGING SYSTEMClarity Medical Systems · 2008-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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