# FDA recall Z-1564-2020

> **Capintec Inc** · Class II · device recall initiated 2020-03-03.

## Product

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.

## Reason for recall

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.

## Distribution

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)

## Key facts

- **Recall number:** Z-1564-2020
- **Recalling firm:** Capintec Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-03
- **Report date:** 2020-04-01
- **Termination date:** 2021-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Florham Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2020

## Citation

> AI Analytics. FDA recall Z-1564-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1564-2020. Source: US FDA. Licensed CC0.

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