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U.S. Department of Health and Human Services

Class 2 Device Recall Mobilett Mira Mobile Xray

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 Class 2 Recall
Mobilett Mira Mobile Xray
see related information
Date Posted August 05, 2013
Recall Status1 Open
Recall Number Z-1875-2013
Recall Event ID 65605
Premarket Notification
510(K) Number
K111912 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Mobiletta Mira Mobile X-ray System
Code Information Model number 10273100
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Siemens Customer Service
888-826-9702
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 39
Distribution US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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