Z-0980-2022Class II

Artis Q.zen biplane, Model Number 10848355

Name: Z-0980-2022 Artis Q.zen biplane, Model Number 10848355
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.zen biplane, Model Number 10848355 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-0980-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-23
Posted: 2022-04-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q.zen biplane, Model Number 10848355
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: 69 systems
Distribution: US Nationwide.
Product codes and lots: UDI: 4056869010038; Serial Numbers: 123225 123245 123026 123043 123031 123053 123202 123050 123248 123008 123255 123252 123259 123035 123211 123247 123011 123003 123032 123208 123209 123231 123246 123254 123025 123036 123220 123221 123222 123206 123207 123268 123240 123262 123265 123219 123505 123213 123250 123251 123022 123229 123205 123502 123201 123023 123024 123224 123232 123233 123234 123501 123027 123049 123249 123055 123056 123037 123264 123010 123046 123052 123200 123015 123016 123244 123212 Additional Serial Numbers as of 10/4/23: 123216 123239

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2022
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)