FDA Medical Device Recalls (openFDA)
Atom Medical Corporation: Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
- Recall number
- Z-0338-2012
- Recalling firm
- Atom Medical Corporation
- Product
- Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
- Status
- Terminated
- Initiated
- 2011-08-23
- Posted
- 2011-12-01
- Terminated
- 2013-09-09
- Reason
- The caster with lock on the 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 ); 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- All lots on the market. model 101
- 510(k) numbers
- ["K102226"]
- PMA numbers
- not on file
- Product code
- FMZ
- Firm FEI
- 3005652389
- Firm city
- Bunkyo-Ku
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28