Device recall

Z-1547-2009: BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC…

FDA device recall · Class II · Brainlab AG

Key facts

Recall number (Z-number) Z-1547-2009
Recall event 51484
Product BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding…
Product code IYE
Recalling firm Brainlab AG
Recall class Class II
Status Terminated
Termination date Aug 19, 2010
510(k) numbers K004022
FEI number 3002619595

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

Browse all FDA device recalls (products)