Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 30, 2024
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then dir…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Shimadzu Corporation Medical Systems Division recalled Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This … — a moderate-severity action.
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This … was recalled by Shimadzu Corporation Medical Systems Division in October 30, 2024. Reason: If digital angiography system is used with a specific catheterization table and the operator directs simultan…. Check the official notice for the remedy. Verify recall #Z-0139-2025 with the FDA Devices before acting.
The recall
Shimadzu Corporation Medical Systems Division issued this moderate-severity FDA Devices recall — If digital angiography system is used with a specific catheterization table and the operator directs simultan….
- Moderate
- severity level
- 13 units
- affected scope
- Class II
- classification
- October 30, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0139-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0139-2025) was formally reported on October 30, 2024, with the manufacturer initiating the action on September 6, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Shimadzu Corporation Medical Systems Division is listed as the recalling firm, operating out of Kyoto, N/A. Federal records list the affected scope as 13.
The documented reason for this recall is: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
13
Related Recalls
6
6 from same agency
Product description
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Reason for recall
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0139-2025 |
| Date reported | October 30, 2024 |
| Date initiated | September 6, 2024 |
| Recalling firm | Shimadzu Corporation Medical Systems Division |
| Firm location | Kyoto, N/A |
| Affected scope | 13 |
| Distribution | US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0139-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.. Recalled by Shimadzu Corporation Medical Systems Division. Units affected: 13.
Why was this product recalled? ▼
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0139-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0139-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 30, 2024.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.