The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body in

FDA device recall Z-2680-2014 · posted 2014-09-23 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.

Action taken

The firm, Siemens, sent a "Safety Advisory Notice" dated August 27, 2014, to end users/customers. The notice identified the product, problem, and action to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization who have to be aware of this problem; forward this safety information to other organizations affected by this measure; and if the device has been sold and therefore no longer in your possession, forward to new owner. Siemens prepared a field modification of the Ysio systems with a hardware upgrade. This field modification will be available in September 2014. If you have any questions, please contact Regulatory Specialist at 610-219-4334 or Customer support at 610-219-6300.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KPR

Quantity affected

62

Distribution

Nationwide Distribution.

Date initiated

2014-08-27

Date posted

2014-09-23

Date terminated

2015-03-30

Location

Malvern, PA

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