Recalls / —

—#52646

Product

Sienet MagicStore. Radiological Digital Image Communications System

FDA product code

LMD — System, Digital Image Communications, Radiological

Device class

Class 1

Medical specialty

Radiology

510(k) numbers

K920310

Affected lot / code info

Model number 7502052 Serial numbers 1793, 1804, 1867, 1920, 1966, 1968, 1983, 2055, 2099, 2527, 2601, 2610, 2618, 2632, 2635, 2638, 2678, 2686, and 2689.

Why it was recalled

System could crash and result in data loss.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Safety Advisory letter to their customers (May 2, 2007) to inform them of the problem. A company representative will be contacting the customers to arrange for replacement of the RAID component.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The products were shipped to medical facilities in CA, CO, FL, MS, NH, NJ, NY, and WA.

Timeline

Recall initiated

2007-05-02

Posted by FDA

2007-06-05

Terminated

2008-09-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #52646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.