—#167128

Product

Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081722
Affected lot / code info: Serial Number 23071 22776 23623 23678 22787 23021 22848 22288 22960 23082 22501 23029 23163 23164 23518 23519 22517 23538 23097 22781 23147 22506 22634 22844 23427 23169 23529 22880 23699 22429 23640 22650 22737 22542 22176 22500 22350 22247 22347 22724 22725 22895 22833 22955 22058 23400 22847 22852 22367 22600 23650 23651 22705 22928 22609 23136 23133 23137 23556 22543 23474 22821 23517 23118 23410 22789 22208 22632 23022 23024 23132 23663 23149 22743 22851 22175 23602 23018 23019 22166 22170 22945 23476 22869 23726 23035 22431 22777 22859 22861 22824 22693 22757 22651 22171 22630 23619 22941 22957 22366 23098 22998 22427 23168 22729 23459 23625 23627 22748 23054 23063 23578 23177 22352 22353 22354 23597 22736 22618 22828 22458 22695 22644 23141 22211 23059 23079 23078 23167 23464 22184 22804 22392 22234 22235 22289 22795 23172 23173 22592 22271 22914

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-08-06
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167128. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.