Nidek Inc: Medical Device Recall in 2014 - (Recall #: Z-2132-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

Product Classification:

Class II

Date Initiated: June 9, 2014

Date Posted: August 6, 2014

Recall Number: Z-2132-2014

Event ID: 68766

Reason for Recall:

Laser aperture label was not affixed to device prior to shipment in the US.

Status: Terminated

Product Quantity: 29 units (26 already re-labeled)

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.

Voluntary or Mandated:

Voluntary: Firm initiated