Reported Aug 6, 2014 · Terminated
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
- Lot codes and dates
- Part number173530U20
- Serial numbers
500105012750136502775031050311503305033150357. 5035850359503825038350408. 504175041850426504395044550446504715051450552505585057350600506105061150651
- Amount recalled
- 29 units (26 already re-labeled)
Where it was sold
Why it was recalled
Laser aperture label was not affixed to device prior to shipment in the US.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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