Device recall

Z-0130-2008: GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers…

FDA device recall · Class II · AMS Innovative Center - San Jose

Key facts

Recall number (Z-number) Z-0130-2008
Recall event 38336
Product GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.
Product code GEX
Recalling firm AMS Innovative Center - San Jose
Recall class Class II
Status Terminated
Termination date Mar 23, 2010
510(k) numbers K010284, K062719
FEI number 2937094

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)