Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 2

FDA device recall Z-0649-2014 · posted 2014-01-08 · Terminated

Recall details

Recalling firm

Optimedica Corporation

Reason for recall

Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.

Action taken

The firm, OptiMedica, issued an "ADVISORY NOTICE" dated December 20, 2013 to all customers with a Catalys Precision Laser System via Federal Express. OptiMedica also released a Field Service Bulletin (Document No: SB-00065) internally for the impacted product with instructions to implement the corrections through the OptiMedica service organization. The notice describes the product, problem and actions to be taken. The customers were instructed to complete the site header information on the attached fax-back form and return via fax to 1-408-890-4681 within the next three (3) business days or mail to OptiMedica at 1310 Moffette Park Drive, Sunnyvale, CA 94089. If you have any questions related to the operation of the Catalys Precision Laser System or the documentation requirements associated with this letter, please call OptiMedica Technical Support at 1-855-662-0911 and you will be directed to an OptiMedica representative who will be pleased to assist you.

Root cause

Under Investigation by firm

Status

Terminated

Product code

OOE

Quantity affected

78 (39 in US, 39 internationally)

Distribution

Worldwide Distribution: US (nationwide) including states of: TX, NC, OH, IA, UT, KY, ME, CA, NY, MA. NJ, IL, PA,, TN, FL, MO, GA, HI, SC, NE, MI, and GA and countries of: Dominican Republic, Germany,

Date initiated

2013-12-20

Date posted

2014-01-08

Date terminated

2014-06-26

Location

Sunnyvale, CA

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