Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Reported: December 12, 2018 Initiated: November 5, 2018 #Z-0551-2019
Product Description
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
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.
Details
- Recalling Firm
- Capintec Inc
- Units Affected
- 65
- 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.
- Location
- Florham Park, NJ
Frequently Asked Questions
What product was recalled? ▼
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138. Recalled by Capintec Inc. Units affected: 65.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2018. Severity: Moderate. Recall number: Z-0551-2019.
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