Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
FDA device recall Z-0988-2015 · posted 2015-01-15 · Terminated
Recall details
- Recalling firm
- Ziemer Usa Inc
- Reason for recall
- The devices were not shipped with the Starter Kits.
- Action taken
- Notification letters dated December 18, 2014 were sent to all direct account s(customers). The letters were included with the Starter Kit referred to in the Surgical Procedure Manual.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 26 lasers
- Distribution
- US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
- Date initiated
- 2014-12-18
- Date posted
- 2015-01-15
- Date terminated
- 2018-02-20
- Location
- Alton, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER (K131207) | Surgical Instrument Engineering AG | 2013-10-09 |