—#129486

Product

AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623
Affected lot / code info: model # 10094200, see distribution list for individual device serial numbers

Why it was recalled

It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Siemens sent a Customer Safety Advisory Notice XP045/14/S, dated August 12, 2014, to direct accounts, which identified the product, problem, and action to be taken to avoid potential risk to patients and users. Customers were instructed to avoid extensive exposure of fluids to the tableside control panel. When cleaning the system, customers were instructed not to appoly excessive fluids, only use damp towels, in accordance with the product manual. Customers were asked to forward the safety notice to any of their customers and to inform Siemens of the identify of the device's new owner where possible. 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

Distribution

Distribution pattern: Nationwide Distribution including IL VA TN PA TX IN MN NM GA MI FL CA NY ME OK MO NJ and AZ.

Timeline

Recall initiated: 2014-08-12
Posted by FDA: 2014-09-16
Terminated: 2015-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129486. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.