FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- Recall number
- Z-2392-2016
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- Status
- Terminated
- Initiated
- 2015-06-30
- Posted
- not on file
- Terminated
- 2016-11-01
- Reason
- The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
- Root cause
- Component design/selection
- Action
- Hitachi sent an Device Correction Notice dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Customers were informed that there is a problem with the Hitachi Medical Systems America, Inc.CT system; the issue is with a power supply in the CT gantry sub-system. During fast rotation (i.e., 35 sec), the centrifugal force applied to the power supply may cause it to fail over time. For further questions, please call (330) 425-1313 ext. 3720.
- Quantity
- 33 units
- Distribution
- US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
- Lot, serial or model codes
- Serial #'s: S5002-S5014; S5017-S5038
- 510(k) numbers
- ["K101888"]
- 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