Atom Air Incu I User Manual

Atom Air Incu I User Manual Download

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The documents listed below are for reference only. For specific operational details, consult the original paper documents included with your product. New generation of hybrid incubator evolved from incubator It is an high-end model in the Atom Infant Incubator series. It supplies two types of warming modes, a radiant heat source from the top, together with a convective heat source, when the hood is closed. Viamed Ltd, established in 1977, has built a strong reputation for the design, manufacture and distribution of a wide range of quality medical equipment; from pulse oximetry and oxygen monitoring devices, used during patient monitoring, through to neonatal intensive care equipment such as infant resuscitation and warming and phototherapy devices.

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Class 2 Device Recall Dual Incu i

Z-1945-2012
Date Initiated by Firm	May 01, 2012
Date Posted	July 06, 2012
Recall Status¹	Terminated ³ on January 31, 2013
Recall Event ID	61807
K102226
Incubator, neonatal - Product CodeFMZ
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
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Device Design
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 (kira0010utc@atomed.co.jp, t0010sugino@atomed.co.jp, or matsumoto@atom0010ami.co.jp). All forms should be completed and returned by January 31, 2013. For questions regarding this recall call 512-327-9997.
377 units
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
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 and Original Applicant = ATOM MEDICAL CORPORATION

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