Device recall event

Recall event 97530: Siemens Medical Solutions USA, Inc

FDA device recall · Class I · Open, Classified

Key facts

Recall event number 97530
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class I
Status Open, Classified
510(k) numbers K072237, K101347, K121160, K121434, K130885, K132119, K151579, K153343, K162102, K170396, K173592, K181613 and 10 more

At a glance

  • 10–99 Recalled products (Z-numbers)
  • 10–99 Linked 510(k)s
  • 100–999 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