Class 2 Device Recall Dual Incu i

• Date Initiated by Firm: May 01, 2012
• Date Posted: July 06, 2012
• Recall Status: Terminated on January 31, 2013
• Recall Number: Z-1945-2012
• Recall Event ID: 61807
• 510(K)Number: K102226
• Product Classification: Incubator, neonatal - Product Code FMZ
• Product: Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
• Code Information: All lots on the market of model 100
• Recalling Firm/ Manufacturer: Atom Medical Corporation; 3-18-15 Hongo; Bunkyo-Ku Japan
• For Additional Information Contact: Renee van de Zande; 512-327-9997
• Manufacturer Reason for Recall: There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
• FDA Determined Cause: Device Design
• Action: Atom Medical sent an Urgent Field Safety Notice dated May 1, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify all affected product in their inventory and quarantine them until the rework was complete. Customers were also asked to identify any customers to whom they further distributed the product and to contact their customers at once and arrange a time in whcih the filed service technician could perform the rework. Customers were asked to return the Recall Response Forms to Atom Medical (kirautc@atomed.co.jp, tsugino@atomed.co.jp, or matsumoto@atomami.co.jp). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.
• Quantity in Commerce: 377 units
• Distribution: Worldwide Distribution - USA including PA. Internationally to Japan, Kuwait, Saudi Arabia, Lenanon, Italy, Spain, China, East Europe, Slovakia, Poland, Czech Republic, Ukraine, Egypt, Russia, Algeria, Colombia, Germany, Malaysia, Switzerland, Australia, Europe, Portugal, Iran, Israel, Philippines, UAE, Korea, and Netherlands
• 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