Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging inc
FDA device recall Z-1265-2014 · posted 2014-03-20 · Terminated
Recall details
- Recalling firm
- Clarity Medical Systems Inc
- 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.
- Action taken
- The firm, Clarity, sent a "Field Bulletin" dated March 12, 2014 to customers - risk managers and distributors by e-mail on March 12, 2014. They plan to follow this with a second letter on or about March 28, 2014 which will include a second bulletin, replacement bulbs and installation instructions. Clarity stated in the letter to its customers "In the meantime, you may continue to use your RetCAM 3." If you have any question of concerns, please contact Clarity at +1 925 621 322 or email to: service@retcam.com
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HKI
- Quantity affected
- 234 lamps
- Distribution
- Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Ki
- Date initiated
- 2014-03-07
- Date posted
- 2014-03-20
- Date terminated
- 2014-08-11
- Location
- Pleasanton, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RETCAM 3 OPHTHALMIC IMAGING SYSTEM (K081858) | Clarity Medical Systems | 2008-11-05 |