—#186408

Product

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193326, K201156
Affected lot / code info: Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037

Why it was recalled

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

Root cause (FDA determination)

Software design

Action the firm took

On 3/19/2021, Siemens Healthineers, issued an "URGENT: MEDICAL DEVICE CORRECTION" notice via letter dated 3/192021 to customers informing them of a possible hazard to patients, operators, or other persons and equipment due to a software error which affects ARTIS icono /pheno systems with software VE20C. The customer are instructed to do the following: The user should be aware of the limited system functionality in backup mode and bypass fluoroscopy operating mode (see also Operator Manual, Chapter 6.7: System Operating Modes). In some rare cases, the automatic recovery phase may not be successful within 4 minutes. If necessary, it may be continued with manual recovery according to the Operator Manual instructions, Chapter 3.13: Recovering functions in case of system failures. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. Promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. Siemens will update the affected software to prevent this non-conformity from reoccurring via Update Instruction AX023/21/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. If you have any further questions, contact the Siemens Medical Solution USA, Inc., at 610-448-6478 or email: Meredith.adams@siemens-healthineers.com.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.

Timeline

Recall initiated: 2021-03-19
Terminated: 2021-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.