1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corn
FDA device recall Z-0811-2014 · posted 2014-01-23 · Terminated
Recall details
- Recalling firm
- Ziemer Usa Inc
- Reason for recall
- A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
- Action taken
- A recall notification letter dated April 16, 2013 was mailed to direct accounts. The letter notified the direct accounts of the problem and advised them that a technician would be arriving at their facility during the week of June 2, 2013 to replace the defective controller board. The technician will also perform preventative maintenance on the device at the same time. Direct accounts are advised to contact Ziemer USA, Inc. at 618-462-9301 if they have any questions about this issue.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 5 units
- Distribution
- Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
- Date initiated
- 2013-04-16
- Date posted
- 2014-01-23
- Date terminated
- 2017-12-27
- Location
- Alton, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FEMTO LDV (K112154) | Sie Ag,Surgical Instument Engineering | 2012-03-16 |