Captus 4000e Thyroid Uptake System
Medical device recall Z-1564-2020. Published in FDA’s Enforcement Report on Apr 1, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 1, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 48 (481 additional units added 3/26/20) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
48 (481 additional units added 3/26/20), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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: 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 940533 940189 940207 940314 940334 940386 940129 940062 940122 940218 940266 940327 940347 940348 940349 940350 940381 940407 940440 940442 940491 940492 940493 940494 940515 940516 940517 940076 940354 940388 940476 940477 940478 940534 940535 940186 940322 940342 940402 940453 940305 940392 940247 940335 940346 940028 940174 940267 940268 940272 940195 940204 940270 940332 940393 940207 940357 940213 940452 940001 940002 940003 940004 940007 940008 940009 940010 940011 940012 940013 940014 940015 940016 940017 940018 940021 940022 940023 940024 940025 940026 940027 940029 940030 940031 940032 940033 940034 940037 940039 940040 940041 940042 940043 940045 940046 940047 940050 940051 940052 940053 940054 940055 940056 940057 940058 940063 940064 940067 940068 940069 940070 940071 940072 940073 940074 940075 940077 940077 940078 940079 940080 940082 940083 940085 940086 940087 940088 940089 940090 940093 940094 940095 940097 940098 940099 940100 940101 940103 940104 940105 940106 940107 940108 940109 940110 940111 940112 940113 940114 940115 940116 940118 940119 940120 940121 940123 940124 940124 940125 940126 940127 940128 940129 940130 940131 940133 940134 940135…
FDA’s list runs to 3,758 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US Nationwide, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philippines, Poland, Saudi Arabia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK, and Vietnam. (list updated 3/26/2020)
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 3, 2020.
- FDA classified it on Mar 24, 2020.
- FDA’s Enforcement Report published it on Apr 1, 2020.
- FDA terminated it on Nov 12, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Capintec Inc, of Florham Park, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,758 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.