Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser gen
FDA device recall Z-0223-2015 · posted 2014-11-17 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
- Action taken
- Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary. An Engineering Change Order was issued on June 1, 2012, for inspection and/or replacement of affected fuse holders by Nidek Service Engineers. For further questions please call (510) 353-7785.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LZS
- Quantity affected
- 14 units
- Distribution
- US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
- Date initiated
- 2012-08-06
- Date posted
- 2014-11-17
- Date terminated
- 2014-11-17
- Location
- Fremont, CA
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