Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 6, 2016
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping …
Siemens Medical Solutions USA, Inc recalled Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system… - a moderate-severity action.
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system… was recalled by Siemens Medical Solutions USA, Inc in April 6, 2016. Reason: After importing segmentation results of the left atrium created on the Artis One system, the possibility exis…. Check the official notice for the remedy. Verify recall #Z-1282-2016 with the FDA Devices before acting.
The recall
Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-After importing segmentation results of the left atrium created on the Artis One system, the possibility exis….
- Moderate
- severity level
- Class II
- classification
- April 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1282-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1282-2016) was formally reported on April 6, 2016, with the manufacturer initiating the action on March 11, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records list the affected scope as 1 angiography system.
The documented reason for this recall is: After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc. Distribution data in the federal record shows the product reached: Nationwide Distribution to Michigan only. 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 angiography system
Related Recalls
6
3 from same agency
Product description
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
Reason for recall
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1282-2016 |
| Date reported | April 6, 2016 |
| Date initiated | March 11, 2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Firm location | Malvern, PA |
| Affected scope | 1 angiography system |
| Distribution | Nationwide Distribution to Michigan only |
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-1282-2016) 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? ▼
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1 angiography system.
Why was this product recalled? ▼
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1282-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to Michigan only.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1282-2016) 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 April 6, 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.