Recalls / —

—#139934

Product

CIOS ALPHA; image intensified fluoroscopic x-ray system

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K132094

Affected lot / code info

model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

Why it was recalled

patient procedure interruption due to a potential system failure

Root cause (FDA determination)

Device Design

Action the firm took

Customer Safety Advisory Notice XP038/15/S, dated August 17, 2015, was sent to direct accounts to alert them to the issue and provide work-around instructions to avoid potential risks.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2015-08-17

Terminated

2016-12-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #139934. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.