—#168937

Product

Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego 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: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: Serial nos: 910045-09 911354-02 910045-19 908883-23 910045-15 910045-14 910045-25 908883-04 911354-25 908883-18 908883-11 910045-21 911354-26 908883-06 908883-02 911354-27

Why it was recalled

This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of this product may have a potential impact on planned procedures as they may be delayed as well as in emergent cases, as clinical treatment may need to be terminated and transferred to a functioning system.

Root cause (FDA determination)

Process control

Action the firm took

On October 26, 2018, the firm, Siemens Healthineers, distributed "URGENT: MEDICAL DEVICE CORRECTION" letters to affected customers. The letters informed customers of the product, problem and actions to be taken. The customers were instructed to do the following: promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and Immediately examine your inventory and quarantine product subject to recall (if applicable). 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 and inform us of the identity of the device's new owner where possible. The letter also stated that Siemens will replace the coolant pump on affected lots of cooling units to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action with Update Instruction AX013/18/S. To request an earlier appointment, feel free to contact the service organization at 1-800-888-7436. If you have any questions, contact Regulatory Technical Specialist at 610-219-4834 or email to: anastasia.sokolova@siemens-healthineers.com.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Distribution to states of: AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, and UT.

Timeline

Recall initiated: 2018-10-26
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.