Recall Z-1564-2020— Capintec Inc
Class II · Terminated
Class II FDA medical device recall by Capintec Inc, initiated 2020-03-03, terminated 2021-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Capintec Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-03
- Terminated
- 2021-11-12
- Firm location
- Florham Park, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.