Device recall event

Recall event 99769: Philips North America Llc

FDA device recall · Class II · Open, Classified

Key facts

Recall event number 99769
Recalling firm Philips North America Llc
Recall class Class II
Status Open, Classified
510(k) numbers K030520, K052013, K052078, K063559, K110151, K183063, K190461, K193215, K213516, K213583, K223442, K223458 and 2 more

At a glance

  • 10–99 Recalled products (Z-numbers)
  • 10–99 Linked 510(k)s
  • 10–99 Recall events for this firm

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recall events

A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recall events