Recall Z-1265-2014— Clarity Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Clarity Medical Systems Inc, initiated 2014-03-07, terminated 2014-08-11. It names one FDA 510(k) clearance: K081858. 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: 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..
- Recalling firm
- Clarity Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-07
- Terminated
- 2014-08-11
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.