Device recall: Artis zee floor, Model Number 10094135
Class II FDA enforcement event 89860. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
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 23 Feb 2022. The firm address in the FDA record is in Malvern, PA. FDA put the recall in Class II. FDA event 89860 has 14 product records. The first FDA enforcement report date is 27 Apr 2022. The record gives the status Ongoing.
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.
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
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0967-2022 | Artis zee floor, Model Number 10094135 | 305 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0968-2022 | Artis zee ceiling, Model Number 10094137 | 709 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0969-2022 | Artis zee multi-purpose, Model Number 10094139 | 277 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0970-2022 | Artis zee biplane, Model Number 10094141 | 373 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0971-2022 | Artis zee floor MN, Model Number 10094142 | 24 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0972-2022 | Artis zee biplane MN, Model Number 10094143 | 7 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0973-2022 | Artis zeego, Model Number 10280959 | 183 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0974-2022 | Artis Q floor, Model Number 10848280 | 80 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0975-2022 | Artis Q ceiling, Model Number 10848281 | 418 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0976-2022 | Artis Q biplane, Model Number 10848282 | 269 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0977-2022 | Artis Q zeego, Model Number 10848283 | 38 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0978-2022 | Artis Q.zen floor, Model Number 10848353 | 33 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0979-2022 | Artis Q.zen ceiling, Model Number 10848354 | 81 systems | Class II | Ongoing | 27 Apr 2022 |
| Z-0980-2022 | Artis Q.zen biplane, Model Number 10848355 | 69 systems | Class II | Ongoing | 27 Apr 2022 |
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 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 14Median of the firm: 1
- Events of the firm on the register
- 400
Other events of the firm
Official channels
- FDA enforcement report Z-0967-2022The 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.
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Cite this page
Recall Register. FDA enforcement event 89860. https://recallregister.com/fda/ii/89860/. 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.
- What quantity of product is in FDA event 89860?
- The event has 14 product records. The first record gives this quantity:
305 systems
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.