Halogen Lamp component in RetCam 3 System — Class II medical device recall Z-1265-2014
Terminated recall by Clarity Medical Systems Inc, reported 2014-03-26, distributed nationwide. One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could resu
| Recall number | Z-1265-2014 |
|---|---|
| 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 | 2014-03-07 |
| Classified | 2014-03-20 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2014-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, CN, DE, EG, FR, GB, IL, IN, IT, JP, KW, MX, NL, PE, PH, SE, TH |
| Quantity | 234 lamps |
| Serial numbers | RC3066, RC3079, RC6013, RC6033, RC6034, RC6035, RC6036, RC6037, RC6038, RC6039, RC6040, RC6041, RC6043, RC6044, RC6045, RC6047, RC6049, RC6050, RC6053, RC6054, RC6055, RC6056, RC6057, RC6058, RC6059 and 92 more |
| Model numbers | 21-100500 |
Product
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.
Reason for recall
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.
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-1265-2014. 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.