Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
FDA device recall Z-1945-2012 · posted 2012-07-06 · Terminated
Recall details
- Recalling firm
- Atom Medical Corporation
- 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 taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMZ
- Quantity affected
- 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,
- Date initiated
- 2012-05-01
- Date posted
- 2012-07-06
- Date terminated
- 2013-01-31
- Location
- Bunkyo-Ku, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL INCU I (K102226) | Atom Medical Corporation | 2011-01-04 |