Device recall

Z-0002-2015: Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals…

FDA device recall · Class II · Siemens Medical Solutions USA, Inc

Key facts

Recall number (Z-number) Z-0002-2015
Recall event 69258
Product Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It…
Product code KPR
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date Feb 24, 2015
510(k) numbers K133259
FEI number 2240869

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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