FDA Medical Device Recalls (openFDA)
Capintec Inc: Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
- Recall number
- Z-0550-2019
- Recalling firm
- Capintec Inc
- Product
- Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
- Status
- Terminated
- Initiated
- 2018-11-05
- Posted
- 2018-12-04
- Terminated
- 2020-06-30
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZD
- Firm FEI
- 3000123149
- Firm city
- Florham Park
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28