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U.S. Department of Health and Human Services

Class 2 Device Recall Infa Warmer i

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  Class 2 Device Recall Infa Warmer i see related information
Date Initiated by Firm August 23, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on September 09, 2013
Recall Number Z-0340-2012
Recall Event ID 59767
510(K)Number K102226  
Product Classification Incubator, neonatal - Product Code FMZ
Product Infa Warmer i (Atom Infant Warmer Model 103)

Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033

Usage: A warmer for infants.
Code Information All lots on the market.  model 103
Recalling Firm/
Atom Medical Corporation
3-18-15 Hongo
Bunkyo-Ku Japan
Manufacturer Reason
for Recall
The caster with lock on the radiant-warming open type incubator may become loose or break.
FDA Determined
Cause 2
Device Design
Action The firm, Atom Medical, sent an "Urgent: Field Safety Notice" letter dated August 18, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all devices in their inventory and quarantine them until the rework is complete; identify any customers to whom they have further distributed the product; contact their customers at once and arrange a time in which the field service technician can perform the rework (the parts needed to complete the rework will be sent from Atom Medical's export department ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) If you have any questions, contact the Manager Quality Control or Manager, Regulatory Affairs at email addresses above, phone: +81-3-3815-3632 or fax +81-3-3812-3199.
Quantity in Commerce 133 units
Distribution Worldwide distribution: USA (nationwide) including state of: PA and countries of: Algeria, Austria, Australia, China, Egypt, Germany, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Russia, Saudi Arabia, Spain, Switzerland, Thailand, The Netherlands, and UAE.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMZ and Original Applicant = ATOM MEDICAL CORPORATION