Device recall

Z-1250-2015: Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp…

FDA device recall · Class II · Pivotal Health Solutions

Key facts

Recall number (Z-number) Z-1250-2015
Recall event 70473
Product Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor…
Product code ILY
Recalling firm Pivotal Health Solutions
Recall class Class II
Status Terminated
Termination date Mar 9, 2016
510(k) numbers K060134
FEI number 3007278668

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)