—#119699

Product

Mobiletta Mira Mobile X-ray System

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111912
Affected lot / code info: Model number 10273100

Why it was recalled

Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent a Field Safety Notice dated May 2. 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to : 1) Never step or sit on the unit or otherwise put substantial weight on it. 2) Avoid moving the unit over high thresholds for doors or elevators where possible, or do so carefully and slowly. 3) Make sure that no person had his/her extremities under the chassis, also when the unit is not moving. Update instructions were also released to alert customers of the potential risk and to provide a hardware change which is intended to improve corrosion resistance. An acknowledgement of receipt form was also sent out for the field safety notice and requested to be returned to Siemens. For further questions please call (888) 826-9702.

Recalling firm

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

Distribution

Distribution pattern: US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.

Timeline

Recall initiated: 2013-05-02
Posted by FDA: 2013-08-05
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119699. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.