Z-0550-2019Class II

Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

Name: Z-0550-2019 Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Creator: Capintec Inc
Published: 2018-11-05
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2018-11-05 / Terminated

FDA source

Capintec Inc began a recall of Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 on 2018-11-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0550-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-05
Posted: 2018-12-04
Terminated: 2020-06-30
Recalling firm: Mirion Technologies (Capintec), Inc.
Product: Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Product code: IZD Probe, Uptake, Nuclear
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Notification letters were sent to customers on 11/5/18. A Revised Product Alert - Corrective Action letter was sent to customers beginning 1/15/19 due to an expansion of the event.
Quantity in commerce: 385
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, Brazil, Canada, China, Cyprus, Greece, Hong Kong, India, Japan, South Korea, Vietnam.
Product codes and lots: Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0550-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0550-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04
Z-0551-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04

Product code IZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)