Z-0300-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- August 6, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31
Product Description
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.
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.
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.
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