Device recall

Z-1555-2011: Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series…

FDA device recall · Class II · Elekta, Inc.

Key facts

Recall number (Z-number) Z-1555-2011
Recall event 57688
Product Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code IYE
Recalling firm Elekta, Inc.
Recall class Class II
Status Terminated
Termination date Apr 7, 2011
510(k) numbers K982713
FEI number 1037831

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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