Recall Z-1154-2014— Clarity Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Clarity Medical Systems Inc, initiated 2014-01-24, terminated 2014-08-11. It names 3 FDA 510(k) clearances: K102859, K090326, K081858. 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: 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..
- Recalling firm
- Clarity Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-24
- Terminated
- 2014-08-11
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K102859 — RETCAM 3 OPTHALMIC IMAGING SYSTEM
- K090326 — RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
- K081858 — RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.