Z-0974-2022Class II

Artis Q floor, Model Number 10848280

Name: Z-0974-2022 Artis Q floor, Model Number 10848280
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-02-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-02-23 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Q floor, Model Number 10848280 on 2022-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0974-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-23
Posted: 2022-04-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q floor, Model Number 10848280
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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".
Root cause tag: design
FDA root cause: Device Design
Action: An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 2/23/22 was sent to customers. Which steps have to be taken by the user to avoid the possible risks associated with this problem? As also described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water, if necessary: 1. Open the filling gland of the cooling unit. The water surface must be clearly visible above the cooling ribs. 2. Replenish with water (drinking water quality) if cooling liquid is lacking. Please inform the service technician in case of lacking cooling liquid. How will the corrective action be implemented and what is the efficiency of the corrective actions? The tube cooling unit will be equipped with a water level sensor and the software will be updated accordingly. In case the coolant level drops below a certain threshold the following message will be displayed: Tube cooling water level low: Refill as per Operator Manual . Siemens will correct the error with a hardware and software update via Update Instruction AX002/20/S and AX004/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. If you have received this notification by email via Adobe EchoSign, kindly sign with your digital signature to acknowledge that you have read and understand t
Quantity in commerce: 80 systems
Distribution: US Nationwide.
Product codes and lots: UDI: 4056869009971; Serial Numbers: 103221 103217 103218 103345 103409 103340 103439 104007 103302 103232 104016 104005 103391 103404 104027 132002 103334 103354 103359 103030 103335 104012 103220 103013 103384 103035 104029 104020 103039 103050 103365 103279 104025 103285 103286 103207 103222 103230 103295 103310 103430 103432 104047 103001 103239 103353 104013 103444 132502 132500 103048 103315 103263 103356 132000 103028 103241 103293 103388 103389 132003 103245 103348 103253 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 103053 103040 160903 126206 160905 160930 160967 160925 160469

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0968-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0969-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0970-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0971-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0972-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0973-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0974-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0975-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0976-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0977-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0978-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0979-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0980-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21

Product code OWB

K181407Class IIArtis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. / cleared 2018-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)