Reported Sep 14, 2016 · Terminated

e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the…

Siemens Medical Solutions USA, Inc.

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: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061

Is this the product you have?

  • e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ
  • using the following techniquesplanar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV
Lot codes and dates
    • Model numbers 4380213
    • 4380221
    • 5242826
    • 5977066
    • 5977074
    • 5984005
    • 5989079
    • 5989087
    • 5989095
    • 5991109
    • 5991117
    • 5992099
    • 7324119
    • 7324135
    • 7324143
    • 7324150
    • 7760809
    • 7760932
    • 7761161
    • 7823920
    • 7823938
    • 7823946
    • 7823953
    • 7823961
    • 7823979
    • 10151531
    • 10151532
    • 10275879
    • 10413009
    • 10520745
  • Serial numbers

    3,886 of 3,886 codes

    • 2005003
    • 5130
    • 1176
    • 1180
    • 1161
    • 1169
    • 1162
    • 1163
    • 1165
    • 1166
    • 1172
    • 2025
    • 2052
    • 7595
    • RC524
    • RC495
    • 8515
    • 1198
    • 1202
    • 10016
    • 5563
    • 5556
    • 7588
    • 8757
    • 10342
    • 11371
    • 11666
    • 5560
    • 7507
    • 7596
    • 10345
    • 11674
    • 1210
    • 1211
    • 1005
    • 1156
    • 1261
    • 5562
    • 5538
    • 5555
    • 10348
    • 11372
    • 1155
    • 4019
    • 8545
    • 8756
    • 9241
    • 9235
    • 9238
    • 10351
    • 10346
    • 10350
    • 11370
    • 1262
    • 1028
    • 1358
    • 4112
    • 7509
    • 7606
    • 7599
Amount recalled
5451

Where it was sold

Why it was recalled

"We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."

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 Mar 9, 2018 · Data as of Sep 19, 6:03 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.