Device recall event

Recall event 88058: Philips Respironics, Inc.

FDA device recall · Class I · Open, Classified

Key facts

Recall event number 88058
Recalling firm Philips Respironics, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K090248, K091319, K092818, K102465, K111378, K113053, K113068, K122769, K130077, K131882, K131982

At a glance

  • 1–9 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