Z-2132-2014 Class II Terminated
FDA device recall Z-2132-2014 was initiated by Nidek Inc on June 9, 2014 and is designated Class II. Reason for recall: Laser aperture label was not affixed to device prior to shipment in the US. The recall status is terminated (terminated November 24, 2014). Affected quantity: 29 units (26 already re-labeled).
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.