Use cautionMedical device recall · FDA · Published October 16, 2019
Hitachi Scenaria X-ray CT System Recall: Cable Detachment Risk During Scans
Hitachi Medical recalls Scenaria whole-body X-ray CT systems (S5002-S5014, S5017-S5:5044) due to potential cable detachment during scans. Affected units may eject cables, causing safety risks.
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.
Take action
Contact the company
📍Recalling firmHitachi Medical Systems America Inc1959 Summit Commerce Park · Twinsburg, OH 44087-2371
“Hitachi Scenaria X-ray CT System Recall: Cable Detachment Risk During Scans.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66786-hitachi-scenaria-x-ray-ct-system-recall-cable-detachment-risk. Based on FDA recall #Z-0271-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2020%22&limit=1).
The FDA announced on Oct. 16, 2019, that Hitachi Medical Systems America Inc is recalling Hitachi Scenaria Whole-body X-ray CT Systems due to the potential for cables to detach during scanning. The agency said the hazard could cause a cable to eject from the system.
How to tell if you have it
Hitachi Scenaria Whole-body X-ray CT System
Units S5002-S5014, S5017-S5044
The hazard
According to the FDA, there is a possibility that the cables to the controller unit may not be affixed properly. This creates the potential for a cable to detach during scanning and eject from the system.
Context
GovInfoNow's records show Hitachi Medical Systems America Inc has five other recalls on record since Oct. 20, 2017. Other recent recalls of similar products include GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), Philips Spectral CT Recall (Jan. 7, 2026), and GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026).
How to tell if you have this one
Check for Scenaria whole-body X-ray CT systems with model numbers S5002-S5014 or S5017-S5044. These units were sold by Hitachi Medical Systems America Inc.
Brand
Hitachi Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cable Attachment
Inspect the cables to the controller unit for secure attachment. If loose, contact Hitachi Medical for assistance.
Where it went and when
Where it was distributed
Distributed in 15 states and Puerto Rico, and outside the U.S.
Listed by the agency
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Indiana, Iowa, Maryland, Montana, New York, North Carolina, Ohio, Oklahoma, Puerto Rico, South Dakota, Tennessee, Texas, Wyoming.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0271-2020 (October 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0271-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.