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660HD-E Image Management System

Model 72204706 · Smith & Nephew, Inc. · DI 00885556623749

LMB — Device, Digital Image Storage, Radiological · Class I · 21 CFR 892.2010

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-01: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 4/device2019-10: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2/device0103040708100102040611120506081011110304010402
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0303
2019-0402
2019-0702
2019-0804
2019-1001
2020-0101
2020-0201
2020-0401
2020-0602
2020-1102
2020-1202
2021-0501
2021-0601
2021-0801
2021-1002
2021-1104
2023-1102
2024-0302
2024-0402
2025-0101
2025-0402
2026-0202
This device (reports/month)Average device in LMB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations