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U.S. Department of Health and Human Services

Class 2 Device Recall PASCAL and PASCAL Streamline

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 Class 2 Device Recall PASCAL and PASCAL Streamline see related information
Date Posted July 19, 2013
Recall Status1 Terminated on July 19, 2013
Recall Number Z-1774-2013
Recall Event ID 65688
510(K)Number K100019 
Product Classification Laser, ophthalmic - Product Code HQF
Product PASCAL and PASCAL Streamline (532 nm.577 nm);

Treats the patient's eye.
Code Information PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x
Serial numbers:
United States
33057910
33060410
33063610
66078611
66084911
66085111
66085511
Out of United States
OMC-179
11138509
11141209
11147209
11147809
11148910
11149010
11149210
11149710 .
11149810
11150110
11150210
11150410
11150610
11150810
11150910
11151010
1 151110
11151211
33054310
33059310
33059510
33062810"
66075211'
66076711
66077111
66078011
66079911
6608391'1
66084611
66084811
66085011
66085211















































Recalling Firm/
Manufacturer
Topcon Medical Laser Systems, Inc
3130 Coronado Dr
Santa Clara CA 95054-3205
For Additional Information Contact John J. Talirico
408-792-8177
Manufacturer Reason
for Recall
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
FDA Determined
Cause 2
Software design
Action Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.
Quantity in Commerce 7 US, 33 foreign
Distribution Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = OPTIMEDICA CORPORATION
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