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Medical device recalls: December 2011

The FDA posted 44 medical device recall records in December 2011, from 27 recall events by 19 companies. 44 have not been classified yet.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Philips Medical Systems (Cleveland) Inc · 3 events, 6 records
  2. Varian Medical Systems, Inc. Oncology Systems · 3 events, 4 records
  3. SCC Soft Computer · 3 events, 3 records
  4. Varian Medical Systems, Inc. · 2 events, 4 records
  5. Elekta, Inc. · 2 events, 2 records
  6. Atom Medical Corporation · 1 event, 4 records
  7. Zimmer Inc. · 1 event, 4 records
  8. Integra LifeSciences Corp. · 1 event, 3 records

FDA root cause

  1. Device Design · 13
  2. Software design · 11
  3. Nonconforming Material/Component · 5
  4. Process control · 4
  5. Error in labeling · 4
  6. Vendor change control · 3
  7. No Marketing Application · 2
  8. Packaging · 1

Not yet classified (44)

The FDA has posted these records but has not published a class for them yet.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.