Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 4, 2016
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is i
Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
Toshiba American Medical Systems Inc recalled Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 … - a moderate-severity action.
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 … was recalled by Toshiba American Medical Systems Inc in May 4, 2016. Reason: Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aqui…. Check the official notice for the remedy. Verify recall #Z-1560-2016 with the FDA Devices before acting.
The recall
Toshiba American Medical Systems Inc issued this moderate-severity FDA Devices recall-Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aqui….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- May 4, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1560-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1560-2016) was formally reported on May 4, 2016, with the manufacturer initiating the action on April 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Toshiba American Medical Systems Inc is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as 1 unit.
The documented reason for this recall is: Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry. Distribution data in the federal record shows the product reached: US in the state Nevada. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
1 unit
Related Recalls
6
3 from same agency
Product description
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Reason for recall
Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1560-2016 |
| Date reported | May 4, 2016 |
| Date initiated | April 12, 2016 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Firm location | Tustin, CA |
| Affected scope | 1 unit |
| Distribution | US in the state Nevada |
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-1560-2016) 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? ▼
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.. Recalled by Toshiba American Medical Systems Inc. Units affected: 1 unit.
Why was this product recalled? ▼
Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1560-2016.
Where was the recalled product distributed? ▼
Distribution: US in the state Nevada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1560-2016) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 4, 2016. 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 July 2026.