Recall Z-1945-2012 ยท FMZ Incubator, Neonatal
Atom Medical Corporation
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.
| Date | Jul 6, 2012 (initiated May 1, 2012) |
| Status | Terminated |
| Reason | There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode. |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102226 | DUAL INCU I Atom Medical Corporation, Jan 4, 2011 |