—#130745

Product

Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341

Why it was recalled

The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.

Root cause (FDA determination)

Process control

Action the firm took

Planned action (s) to repair defect or to bring product into compliance for Siemens Medical Solutions Inc. concerning the corrective action plan (CAP) for the Model(s) Artis Zee/Zeego Stationary Angiographic X-ray Systems. 1.Notifying the customer of the defect. 2.Implementing a corrective software patch to protect the system from damage in the event of hardware failure 3. Scheduling a service visit from a Siemens representative to perform a hardware replacement. 4. Replacing the non-conforming X-ray tube with one manufactured after the nonconformity issue was resolved. For further questions please call (610) 219-6300.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Mail Code: 65-1A, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.

Timeline

Recall initiated: 2014-09-17
Posted by FDA: 2015-01-14
Terminated: 2015-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.