Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033

FDA device recall Z-0339-2012 · posted 2011-12-01 · Terminated

Recall details

Recalling firm

Atom Medical Corporation

Reason for recall

The caster with lock on the incubator may become loose or break.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FMZ

Quantity affected

32 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 Ara

Date initiated

2011-08-23

Date posted

2011-12-01

Date terminated

2013-09-09

Location

Bunkyo-Ku, Japan

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