—#125728

Product

MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K121513
Affected lot / code info: model nos. 10746665, 10746666, 10847610, 10746700

Why it was recalled

It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243 and Torque 10nm during system installation. Siemens initiated the update instruction to verify and secure the hose holder with Loctite 243. A PCB D802 Rev. 00 b

Root cause (FDA determination)

Process change control

Action the firm took

Affected customers were initially notified with a recall letter on/about 2/12/14 and were sent Update Instructions to affected customers.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.

Timeline

Recall initiated: 2014-02-13
Posted by FDA: 2014-04-24
Terminated: 2015-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.