FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
- Recall number
- Z-0152-2007
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
- Status
- Terminated
- Initiated
- 2006-08-14
- Posted
- 2006-11-04
- Terminated
- 2012-09-19
- Reason
- Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
- Root cause
- Other
- Action
- The recalling firm issued a Device Correction letter to the clinic customer on 9/15/2006 making them aware of this potential problem and of their completed corrective action on 8/14/2006, by a Service Rep visit.
- Quantity
- 1 unit
- Distribution
- The recalled unit was distributed to a single customer.
- Lot, serial or model codes
- Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
- 510(k) numbers
- ["K052172"]
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
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