Device recall: AXIOM Artis FC, Model Number 5904433
Class II FDA enforcement event 83203. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Siemens Medical Solutions USA, Inc started this device recall on 12 Jun 2019. The firm address in the FDA record is in Malvern, PA. FDA put the recall in Class II. FDA event 83203 has 23 product records. The first FDA enforcement report date is 31 Jul 2019. The record gives the status Terminated, with the termination date 18 Sep 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution
Recalling firm
Siemens Medical Solutions USA, Inc, Malvern, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
23 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2012-2019 | AXIOM Artis FC, Model Number 5904433 | 5 | Class II | Terminated | 31 Jul 2019 |
| Z-2013-2019 | AXIOM Artis FA, Model Number 5904441 | 4 | Class II | Terminated | 31 Jul 2019 |
| Z-2014-2019 | AXIOM Artis MP, Model Number 5904466 | 24 | Class II | Terminated | 31 Jul 2019 |
| Z-2015-2019 | AXIOM Artis BC, Model Number 5904649 | 6 | Class II | Terminated | 31 Jul 2019 |
| Z-2016-2019 | AXIOM Artis BA, Model Number 5904656 | 7 | Class II | Terminated | 31 Jul 2019 |
| Z-2017-2019 | AXIOM Artis dBC, Model Number 5917054 | 1 | Class II | Terminated | 31 Jul 2019 |
| Z-2018-2019 | AXIOM Artis TA, Model Number 7007755 | 5 | Class II | Terminated | 31 Jul 2019 |
| Z-2019-2019 | AXIOM Artis dTA, Model Number 7008605 | 178 | Class II | Terminated | 31 Jul 2019 |
| Z-2020-2019 | AXIOM Artis dFC, Model Number 7412807 | 148 | Class II | Terminated | 31 Jul 2019 |
| Z-2021-2019 | AXIOM Artis dTC, Model Number 7413078 | 98 | Class II | Terminated | 31 Jul 2019 |
| Z-2022-2019 | AXIOM Artis dBA, Model Number 7555357 | 85 | Class II | Terminated | 31 Jul 2019 |
| Z-2023-2019 | AXIOM Artis dMP, Model Number 7555365 | 32 | Class II | Terminated | 31 Jul 2019 |
| Z-2024-2019 | AXIOM Artis dFA, Model Number 7555373 | 39 | Class II | Terminated | 31 Jul 2019 |
| Z-2025-2019 | AXIOM Artis dFC, Model Number 7727717 | 19 | Class II | Terminated | 31 Jul 2019 |
| Z-2026-2019 | AXIOM Artis TC, Model Number 7728350 | 1 | Class II | Terminated | 31 Jul 2019 |
| Z-2027-2019 | AXIOM Artis dBC, Model Number 7728392 | 53 | Class II | Terminated | 31 Jul 2019 |
| Z-2028-2019 | Artis zee floor, Model Number 10094135 | 170 | Class II | Terminated | 31 Jul 2019 |
| Z-2029-2019 | Artis zee ceiling, Model Number 10094137 | 428 | Class II | Terminated | 31 Jul 2019 |
| Z-2030-2019 | Artis zee multi, Model Number 10094139 | 89 | Class II | Terminated | 31 Jul 2019 |
| Z-2031-2019 | Artis zee biplane, Model Number 10094141 | 268 | Class II | Terminated | 31 Jul 2019 |
| Z-2032-2019 | Artis zee floor MN, Model Number 10094142 | 23 | Class II | Terminated | 31 Jul 2019 |
| Z-2033-2019 | Artis zee biplane MN, Model Number 10094143 | 3 | Class II | Terminated | 31 Jul 2019 |
| Z-2034-2019 | Artis zeego, Model Number 10280959 | 117 | Class II | Terminated | 31 Jul 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 23Median of the firm: 1
- Events of the firm on the register
- 400
Other events of the firm
Official channels
- FDA enforcement report Z-2012-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 83203. https://recallregister.com/fda/ii/83203/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution
- What quantity of product is in FDA event 83203?
- The event has 23 product records. The first record gives this quantity:
5
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.