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

FDA device recall Z-1564-2020 · posted 2020-03-24 · Terminated

Recall details

Recalling firm

Capintec Inc

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.

Action taken

Important Captus 4000e Safety Notice, Action Required letters dated 3/3/20 were sent to customers. As a precautionary measure, Capintec is requesting customers, whose systems include collimators from the same batch, perform a simple safety inspection. A detailed and easy to follow inspection procedure is included. The inspection can be performed in a few minutes, and any defect would be easily identified. Please confirm completion of inspection process by completing the attached form (page 2) and return to Capintec, Inc. For additional assistance or information, email capintec.techsupport@capintec.com or call 1-800-631-3826 and request technical support. A REVISED March 26, 2020 TO EXTEND SERIAL NUMBER RANGE notification letter was sent to customers: In February 2019, Capintec received a complaint that a collimator fell from a Captus 4000e system. A second complaint of a similar nature was received in September 2019. After evaluation of the failed components, it is possible that the collimators had screw hole locations that were insufficiently tapped. It is believed that the failures occurred after impact to the arm. Both collimators are believed to have originated from the same batch. It is possible other collimators from this batch may have a similar defect. It is also possible that all other collimators from the same batch are without issue and functioning satisfactorily. As a precautionary measure, Capintec is requesting customers, whose systems include collimators from the same batch, perform a simple safety inspection. A detailed and easy to follow inspection procedure is included. The inspection can be performed in a few minutes, and any defect would be easily identified. Please confirm completion of inspection process by completing the attached form (page 2) and return to Capintec, Inc.For additional assistance or information, email capintec.techsupport@capintec.com or call 1-800-631-3826 and request technical support.

Root cause

Device Design

Status

Terminated

Product code

IZD

Quantity affected

48 (481 additional units added 3/26/20)

Distribution

Worldwide distribution. US Nationwide, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philipp

Date initiated

2020-03-03

Date posted

2020-03-24

Date terminated

2021-11-12

Location

Florham Park, NJ