RetCam 3 — Class II medical device recall Z-1154-2014

Terminated recall by Clarity Medical Systems Inc, reported 2014-03-19, distributed nationwide. Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2

Recall number	`Z-1154-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Clarity Medical Systems Inc, Pleasanton, CA, United States
Recall initiated	2014-01-24
Classified	2014-03-07
Reported by FDA	2014-03-19
Terminated	2014-08-11
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BD, BG, BR, CA, CH, CL, CN, CZ, DE, DK, DZ, EC, EG, FI, FR, GB, ID, IL, IN, IR, IT, KW, LB, MX, MY, NL, OM, PE, PH, PK, PL, PT, SA, SE, TH, TR, TW
Reason classes	software
Serial numbers	`RC3125`, `RC6003`, `RC6004`, `RC6005`, `RC6006`, `RC6007`, `RC6008`, `RC6009`, `RC6010`, `RC6011`, `RC6012`, `RC6013`, `RC6014`, `RC6015`, `RC6016`, `RC6017`, `RC6018`, `RC6019`, `RC6020`, `RC6021`, `RC6022`, `RC6023`, `RC6024`, `RC6025`, `RC6026` and 451 more
Model numbers	`20-000300`, `21-100500`, `23-00100`

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1154-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.