Device recall: AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO…
Class II FDA enforcement event 94777. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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 31 May 2024. The firm address in the FDA record is in Malvern, PA. FDA put the recall in Class II. FDA event 94777 has 9 product records. The first FDA enforcement report date is 3 Jul 2024. 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 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
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2180-2024 | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399 | 50 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2181-2024 | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415 | 7 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2182-2024 | AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381 | 12 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2183-2024 | AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431 | 20 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2184-2024 | AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543 | 2 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2185-2024 | AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718 | 4 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2186-2024 | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517 | 3 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2187-2024 | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525 | 3 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2188-2024 | ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900 | 2 units | Class II | Ongoing | 3 Jul 2024 |
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 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 9Median of the firm: 1
- Events of the firm on the register
- 400
Other events of the firm
Official channels
- FDA enforcement report Z-2180-2024The 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 94777. https://recallregister.com/fda/ii/94777/. 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 94777?
- The event has 9 product records. The first record gives this quantity:
50 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.