FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi Scenaria Whole-body X-ray CT System
- Recall number
- Z-0271-2020
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi Scenaria Whole-body X-ray CT System
- Status
- Terminated
- Initiated
- 2019-10-16
- Posted
- not on file
- Terminated
- 2020-04-30
- Reason
- There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers. Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling. Please contact me if you need further information regarding this report. You can send any questions, comments or requests to recalls@hitachihealthcare.com.
- Quantity
- 39
- Distribution
- The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico.
- Lot, serial or model codes
- Scenaria units S5002-S5014, S5017-S5044
- 510(k) numbers
- ["K101888","K150595"]
- PMA numbers
- not on file
- Product code
- JAK
- 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