—#102094

Product

Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040675
Affected lot / code info: Model number 10094012; serial numbers 20202, 20223, 20231, 20422, 20402, 20435, 21022, 22002, 21005, and 20432. Model number 7008530; serial numbers 20146, 21112, 20003, 20115, 20135, 20006, 20113, and 20120.

Why it was recalled

When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240:

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Siemens sent a "Customer Safety Advisory Notice" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT.

Timeline

Recall initiated: 2011-06-29
Posted by FDA: 2011-08-11
Terminated: 2014-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102094. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.