Recalls / —

—#86657

Product

Axiom Artis MP, Model number 5904466 angiographic x-ray systems

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K010721

Affected lot / code info

Serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20052, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363.

Why it was recalled

c-arm may tilt

Root cause (FDA determination)

Other

Action the firm took

The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2009-10-26

Posted by FDA

2009-12-03

Terminated

2010-01-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #86657. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.