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Medical device recalls: November 2006

The FDA posted 114 medical device recall records in November 2006, from 66 recall events by 57 companies. 114 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. Access Point Medical LLC · 2 events, 6 records
  2. Philips Medical Systems North America Co. Phillips · 2 events, 4 records
  3. Data Innovations, Inc. · 2 events, 3 records
  4. Plus Orthopedics USA · 2 events, 3 records
  5. Siemens Medical Solutions USA, Inc · 2 events, 3 records
  6. Datex - Ohmeda, Inc · 2 events, 2 records
  7. MAQUET Inc. · 2 events, 2 records
  8. Michigan Instruments, Inc. · 2 events, 2 records

FDA root cause

  1. Other · 107
  2. Software change control · 2
  3. Process control · 2
  4. Process change control · 2
  5. Nonconforming Material/Component · 1

Not yet classified (114)

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.