Device recall event

Recall event 53869: Philips Healthcare Inc.

FDA device recall · Class II · Terminated

Key facts

Recall event number 53869
Recalling firm Philips Healthcare Inc.
Recall class Class II
Status Terminated
510(k) numbers K000794, K030886, K032971, K042601, K051134, K053174, K890517, K893643, K910019, K913516, K920379, K963327 and 1 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