| | Class 2 Recall
Dual Incu i |  |
| Date Posted |
July 06, 2012 |
| Recall Number |
Z-1945-2012 |
| 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 |
| Consumer Instructions |
No consumer action necessary |
| For Additional Information Contact |
Renee van de Zande
512-327-9997
|
Reason for
Recall |
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
|
| 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 |
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