AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal

FDA device recall Z-2649-2014 · posted 2014-09-16 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

OWB

Quantity affected

33

Distribution

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

Date initiated

2014-08-12

Date posted

2014-09-16

Date terminated

2015-05-21

Location

Malvern, PA

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