Recall Z-0340-2012 ยท FMZ Incubator, Neonatal
Atom Medical Corporation
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.
| Date | Dec 1, 2011 (initiated Aug 23, 2011) |
| Status | Terminated |
| Reason | The caster with lock on the radiant-warming open type incubator may become loose or break. |
| Root cause | 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 ); comple |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102226 | DUAL INCU I Atom Medical Corporation, Jan 4, 2011 |