Device Recall Infa Warmer i 의 리콜

Recall

59767

Class 2

Z-0340-2012

2011-08-23

2011-12-01

Terminated

United States

2013-09-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103617

The caster with lock on the radiant-warming open type incubator may become loose or break.

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 ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) If you have any questions, contact the Manager Quality Control or Manager, Regulatory Affairs at email addresses above, phone: +81-3-3815-3632 or fax +81-3-3812-3199.