Mobiletta Mira Mobile X-ray System

FDA device recall Z-1875-2013 · posted 2013-08-05 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

IZL

Quantity affected

39

Distribution

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

Date initiated

2013-05-02

Date posted

2013-08-05

Date terminated

2015-02-24

Location

Malvern, PA

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