Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser
FDA device recall Z-0224-2015 · posted 2014-11-17 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
- Action taken
- Nidek Field Service engineers visited each affected location to upgrade software.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 21affected devices
- Distribution
- US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
- Date initiated
- 2012-10-24
- Date posted
- 2014-11-17
- Date terminated
- 2014-11-17
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228) | Nidek Incorporated | 2011-02-23 |