—#133162

Product

Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133580
Affected lot / code info: Model Number 10848600, serial number 82010

Why it was recalled

The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Root cause (FDA determination)

Process control

Action the firm took

Siemens notified their customer via Customer Safety Advisory Letter AX049/14/S, dated January 16, 2015, and has initiated a fix with Update Instruction AX048/14/S which will be completed by a Siemens service technician. Customers with questions should contact the Customer Care Center at 1-800-888-7436. For questions regarding this recall call 610-219-6300.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution to MI only

Timeline

Recall initiated: 2015-01-16
Posted by FDA: 2015-02-17
Terminated: 2015-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133162. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.