Device recall

Z-0449-2009: Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone…

FDA device recall · Class II · Hologic, Inc.

Key facts

Recall number (Z-number) Z-0449-2009
Recall event 49712
Product Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
Product code KGI
Recalling firm Hologic, Inc.
Recall class Class II
Status Terminated
Termination date Mar 7, 2016
510(k) numbers K080711
FEI number 1221300

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)