Device recall: Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Class II FDA enforcement event 81605. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
Class II, in the words of FDA
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
Capintec Inc started this device recall on 5 Nov 2018. The firm address in the FDA record is in Florham Park, NJ. FDA put the recall in Class II. FDA event 81605 has 2 product records. The first FDA enforcement report date is 12 Dec 2018. The record gives the status Terminated, with the termination date 30 Jun 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US nationwide distributed in the states of AR, AZ, CA, CO, CT, DC, FL, IA, IN, LA, MD, MI, MN, NC, NJ, OH, OK, PA, SC, SD, TX, VA, WI, WV, and countries of Argentina,…
Recalling firm
Capintec Inc, Florham Park, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0550-2019 | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 | 385 | Class II | Terminated | 12 Dec 2018 |
| Z-0551-2019 | Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 | 65 | Class II | Terminated | 12 Dec 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Mar 2020 | Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by t | Device | Class II | 1 |
| 24 Jul 2012 | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technolo | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0550-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 81605. https://recallregister.com/fda/ii/81605/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US nationwide distributed in the states of AR, AZ, CA, CO, CT, DC, FL, IA, IN, LA, MD, MI, MN, NC, NJ, OH, OK, PA, SC, SD, TX, VA, WI, WV, and countries of Argentina,…
- What quantity of product is in FDA event 81605?
- The event has 2 product records. The first record gives this quantity:
385
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.