Device product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Z-2132-2014
Product summary
- Firm
- Nidek Inc
- Event
- Event 68766
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units (26 already re-labeled)
- Official record key
device-enforcement:Z-2132-2014
Official wording
Reason: Laser aperture label was not affixed to device prior to shipment in the US.
Code information: Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.
Distribution pattern: Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Derived failure modes
-
Unknown
Laser aperture label was not affixed to device prior to shipment in the US.