Reported Apr 25, 2018 · Terminated

T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images,…

Philips Electronics North America Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • T10-NT
  • Model 78107 Product UsageIndicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities
Lot codes and dates
  • (Added 6/25/18):

    67 of 67 codes

    • 4170
    • 4113
    • 4082
    • 4176
    • 4147
    • 4319
    • 4397
    • 4285
    • 4308
    • 4408
    • 4241
    • 4064
    • 4328
    • 4312
    • 4294
    • 4296
    • 4009
    • 4274
    • 4258
    • 4297
    • 4246
    • 4200
    • 4041
    • 4207
    • 4327
    • 4318
    • 4089
    • 4102
    • 4222
    • 4025
    • 4321
    • 4177
    • 4015
    • 4088
    • 4106
    • 4260
    • 4183
    • 4272
    • 4416
    • 4365
    • 4047
    • 4411
    • 4254
    • 4301
    • 4261
    • 4307
    • 4267
    • 4386
    • 4033
    • 4099
    • 4251
    • 4339
    • 4374
    • 4162
    • 4322
    • 4320
    • 4069
    • 4006
    • 4273
    • 4418
Amount recalled
8,205 units in total

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Potential risk for helium gas inside the MR examination room during a magnet quench

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 10, 2020 · Data as of Sep 19, 6:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.