system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 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 Recall Z-1299-2016 · Posted 2016-03-31
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2016-02-26
Date Terminated2017-06-21
Product Quantity552 units
Reason for Recall
In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.
Firm Action
The firm, Siemens, sent an "Important Customer Safety Notice" dated 2/16/2016 to its customers. The notice informed them of a corrective action that will be performed to prevent a possible hazard to patients, operators, other persons or equipment. The notice described the product, problem and actions to be taken. Siemens plans to contact each customer to arrange a date to add additional protection mechanisms by means of a system software update.
If you have any questions, contact Engineer, Regulatory Technical Specialist at 610-448-6461 or email: [email protected].
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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