Reported Apr 1, 2020 · Terminated

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by…

Capintec 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: Capintec Inc · 7 Vreeland Rd · Florham Park, NJ · 07932-1511

Is this the product you have?

    • Captus 4000e Thyroid Uptake System
    • Model Numbers 5430-30151
  • and 5430-30152 - Product Usageis intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures
Lot codes and dates
  • Serial Numbers
    • 940146
    • 940124
    • 940127
    • 940134
    • 940147
    • 940110
    • 940123
    • 940117
    • 940120
    • 940105
    • 940106
    • 940115
    • 940118
    • 940136
    • 940137
    • 940114
    • 940141
    • 940142
    • 940113
    • 940148
    • 940103
    • 940121
    • 940135
    • 940150
    • 940122
    • 940128
    • 940129
    • 940109
    • 940104
    • 940119
    • 940107
    • 940145
    • 940125
    • 940126
    • 940130
    • 940131
    • 940112
    • 940149
    • 940132
    • 940108
    • 940111
    • 940116
    • 940133
    • 940144
    • 940152
    • 940153
    • 940154
    • 940155
  • Additional systems added as of 3/26/20

    481 of 481 codes

    • 940005
    • 940065
    • 940265
    • 940317
    • 940325
    • 940370
    • 940406
    • 940514
    • 940061
    • 940368
    • 940369
    • 940375
    • 940376
    • 940484
    • 940485
    • 940486
    • 940528
    • 940200
    • 940217
    • 940522
    • 940038
    • 940044
    • 940048
    • 940059
    • 940060
    • 940066
    • 940081
    • 940084
    • 940096
    • 940151
    • 940228
    • 940229
    • 940243
    • 940271
    • 940336
    • 940337
    • 940338
    • 940355
    • 940413
    • 940431
    • 940435
    • 940451
    • 940473
    • 940300
    • 940405
    • 940148
    • 940019
    • 940020
    • 940006
    • 940435
    • 940035
    • 940145
    • 940102
    • 940157
    • 940175
    • 940261
    • 940356
    • 940358
    • 940521
    • 940164
Amount recalled
48 (481 additional units added 3/26/20)

Where it was sold

  • Nationwide

Why it was recalled

It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.

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 Nov 12, 2021 · Data as of Sep 19, 4:49 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.