Z-2132-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2014
- Initiation Date
- June 9, 2014
- Termination Date
- November 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units (26 already re-labeled)
Product Description
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Reason for Recall
Laser aperture label was not affixed to device prior to shipment in the US.
Distribution Pattern
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
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.