| Class 2 Device Recall Siemens Ysio Max | |
Date Initiated by Firm | August 06, 2018 |
Create Date | October 30, 2018 |
Recall Status1 |
Terminated 3 on April 10, 2020 |
Recall Number | Z-0300-2019 |
Recall Event ID |
80960 |
510(K)Number | K133259 |
Product Classification |
System, x-ray, stationary - Product Code KPR
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Product | Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body. |
Code Information |
Serial Numbers 24077 24221 24256 24237 24263 24327 24297 24283 24288 24289 24172 24174 24186 24129 24277 24142 24304 24109 24176 24049 24058 24039 24234 24323 24105 24295 24121 24230 24276 24194 24281 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | Anastasia Sokolova 610-448-6478 |
Manufacturer Reason for Recall | In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning. |
FDA Determined Cause 2 | Device Design |
Action | Urgent Medical Device Correction notification letters dated 8/6/18 were distributed to customers. The letters instruct customers to do the following:
To avoid the above mentioned risk until implementation of the corrective action, it is strongly recommended not to perform up/down movements of the lifting column directly above the patient. Instead, the vertical movement should be completed beside the patient and then the system should be moved horizontally to the patient.
How will the issue finally be resolved?
Siemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP025/18/S and is planned to be available in the end of August 2018.
How will the corrective action be implemented and how effective is the corrective action?
Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction XP025/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. |
Quantity in Commerce | 31 |
Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPR
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